News On Stem Cell Clinics And Companies

Europe's largest stem cell clinic, which is at the centre of a scandal over the death of a baby given an injection into the brain, has been shut down.

The closure of the XCell-Center in Dusseldorf follows an undercover investigation by The Sunday Telegraph into its controversial practices, which attracted hundreds of patients from the UK. The clinic charged patients up to £20,000 for stem cell injections into the back and brain despite a lack of scientific proof that the treatments actually worked.
 
Experts in stem cell research had accused the clinic of preying on vulnerable patients, desperately seeking a cure for such illnesses and diseases as cerebral palsy, multiple sclerosis, autism, Parkinson's, Alzheimer's, heart disease, diabetes and spinal cord injuries.
 
While most other European countries - as well as the US, Canada and Australia - have banned stem cell treatments unless shown to be safe and effective, XCell had exploited a loophole in German law allowing it to charge for the experimental procedures.

But last week, the clinic suddenly announced it had ceased carrying out operations due to what it described as legal changes in Germany. In a posting on its website, XCell said last week: "Due to a new development in German law, stem cell therapy is currently not possible to perform at the XCell-Center. Regretfully for this reason, we must cancel your appointment until further notice. We will notify you for further updates about the matter."

The clinic had come under increasing scrutiny following the death of an 18-month-old boy in August last year, in a case first revealed by The Sunday Telegraph. The child, who was from Romania, was injected in the brain with stem cells but suffered internal bleeding. Three months earlier, a boy aged 10 from Azerbaijan had almost died when the same procedure went wrong. The doctor who carried out the operation remains under criminal investigation.

The Sunday Telegraph now understands that following this newspaper's report in October, German authorities decided to re-examine the legality of the XCell operation. The centre had previously had permission to practice for a transitional period because it was already up and running when a law came into force in 2009 banning the commercial exploitation of unproven stem cell treatments.
 
It appears German authorities have now decided to close the loophole with immediate effect. They deny the law has changed and sources suggested they decided abruptly to re-interpret it instead.
 
A spokesman for the Paul-Ehrlich Institute, which regulates medicines in Germany, said: "The situation is very complicated but the law on stem cell treatments has not changed. However we welcome the news that the XCell-Center is not accepting any more cases."
 
Ira Hermann, who runs the German stem cell network which funds scientific research projects, said: "XCell was offering unproven treatments and taking a lot of money from very vulnerable people."
 
Professor Chris Mason, chair of regenerative medicine at University College London, said: "This is excellent news for the European cell therapy industry. XCell had failed to demonstrate its treatments were either safe and effective or had scientific rationale."
 
The clinic's sudden closure has taken would-be patients by surprise and left them confused. Some have been told the shut down is temporary and others that it is permanent. They had pinned their hopes on the promise of possible success for currently incurable illnesses.
 
On a Facebook page, one Australian patient posted: "Could you please tell me the approximate waiting list after sending the deposit. We sent the deposit more than two weeks ago and have not heard back even after emailing. We have also called the clinic and left messages for our contact to get back to us to no avail. We are getting a little worried."
 
Carol Walmsley, who lives in the Isle of Man, had hosted a charity night for her son Chris, quadriplegic after a car accident, only last Sunday. Raising the £15,000 needed for his treatment, she telephoned the XCell the following day only to be told the clinic was no longer accepting patients.
 
"It devastated me," said Mrs Walmsley, "They said they were cancelling all operations because they were unable to make any appointments. They said they were booking a meeting with the German government to sort this out. They told me they were fairly confident but there were no guarantees."
 
The XCell clinic treated about 25 patients a year from the UK in state of the art facilities in Dusseldorf, occupying two floors of a general hospital on the outskirts of the city overlooking the River Rhine. The clinic used modern equipment and claimed great success for its treatments although it was always careful not to offer guarantees of cures to patients. The treatment involved taking bone marrow from patients, harvesting stem cells from the bone marrow and then reinjecting those stem cells into other parts of the body.
 
The clinic did not appear to offer up its claims to independent scrutiny while experts suggested any improvement in condition reported by patients after treatment could be caused by the placebo effect.
 
A doctor at the clinic told a Sunday Telegraph undercover reporter, who suffers from multiple sclerosis and is confined to a wheelchair, that he might walk again should he agree to the stem cell treatments.
 
The XCell-Center did not respond to inquiries from The Sunday Telegraph.

Source: The Sunday Telegraph (c) Copyright of Telegraph Media Group Limited 2011 (10/05/11)

A doctor who convinced patients to spend thousands of pounds on his bogus alternative treatments has been struck off the medical register.

A hearing at the General Medical Council ruled that Dr Robert Trossel exploited vulnerable patients who were desperately looking for relief from their Multiple Sclerosis.

Many had raised thousands of pounds to travel for the treatment at Dr Trossel's clinic in Rotterdam.

The 56-year-old had claimed that his unproven stem cell therapy might relieve their symptoms but, instead of using cells from human umbilical cords, he used cells from a cow on four of his patients.

Alarmingly, this was a practice only ever tested on other animals.

The treatment is not licensed in the UK so Dr Trossell saw potential patients at an office in London and then organised for them to be treated in the Netherlands.

The Dutch have since banned the practice as well.

Vicci Chittenden paid £6,000 for her treatment in and still does not know exactly what she was injected with at the clinic.

Like many of his other victims she felt betrayed and told Sky News: "It is the worst possible thing that a human being can do to another human being."

Dr Trossel made no comment as he arrived at the hearing.

Brian Gomes da Costa, chairman of the General Medical Council fitness to practise panel, told Dr Trossel: "You have exploited vulnerable patients and their families.

"You have given false hope and made unsubstantiated and exaggerated claims to patients suffering from degenerative and devastating illnesses.

"Your conduct has unquestionably done lasting harm, if not physically, then mentally and financially, to these patients and also to their families and supporters."

The General Medical Council Ruling

Fitness to Practise Panel – 28 September 2010
Dr Robert Theodore Henri Kees TROSSEL (6049460)
Determination on Sanction (Erasure)

Dr Trossel: The Panel has taken into account all the evidence presented in this case, including the material submitted in mitigation. It has considered the submissions made by both Counsel as well as the advice of the Legal Assessor. The Panel has borne in mind the GMC’s publications, Good Medical Practice and Indicative Sanctions Guidance. It has taken account of all the relevant case law referenced. It has had due regard to the principle of proportionality and the need to act in a manner which is no more severe than necessary. It is conscious that the purpose of a sanction is not to punish and it has given due weight to the mitigation advanced on your behalf. The Panel is conscious of its duty to protect patients and of the public interest and is mindful that it must impose the sanction it deems necessary, notwithstanding any inadvertent punitive effect.

The Panel has found your fitness to practise to be impaired and that your actions have been:
• unjustifiable and without scientific or other clinical/medical basis;
• inappropriate;
• not in the best interests of your patients;
• exploitative of vulnerable patients;
• inconsistent with good clinical practice;
• misleading;
• below the standard expected of a registered medical practitioner, particularly with regard to your failures to:
  - make the care of your patients your first concern;
  - respect the rights of your patients to be fully involved in decisions mde about their care; and
  - obtain informed consent prior to undertaking medical treatment of your patients;
• an abuse of your position as a doctor; and
• (in relation to your police caution) dishonest.

You have been in breach of a number of duties and responsibilities prescribed in Good Medical Practice and your actions are damaging to the reputation of the medical profession. The serious nature of the findings made against you means that this is not a case where ‘no action’ would be appropriate.

It was submitted, on your behalf, that conditions would be an appropriate and sufficient sanction. To impose conditions the Panel must be satisfied that any condition imposed is workable, proportionate, and sufficient.

You have told this Panel, repeatedly, that you believe in the efficacy of your treatments, although you accept that there is no scientific and/or clinical medical evidence to underpin some of your claims. Furthermore, notwithstanding your very recent admissions, the Panel has concluded that in reality you continue to believe that your actions were in the best interests of your patients. The Panel cannot, therefore, rely upon you to make the welfare of your patients your first concern; or be confident that the safety of patients you treat would be ensured.

You have also told the Panel that in future your wife and professional colleagues could ensure that you do not again become ‘over enthusiastic’ in your work. The Panel cannot accept that such an assurance is sufficient to protect patients and the wider public interest; in itself, your suggested informal reliance on others demonstrates a significant lack of insight.

In all the circumstances the Panel cannot be satisfied that conditions would be sufficient adequately to protect patients or the wider public interest. In reaching this decision the Panel has taken into account your wholesale departures from the essential duties of a doctor as set out in Good Medical Practice; your breach of the principles and tenets set out in that document; your reckless, if well intentioned, attitude; and your disregard for the safety of patients.

The Panel next considered whether suspension could be a sufficient and proportionate sanction, giving you time to provide evidence of insight or actions to put matters right. However, you have been suspended from the Medical Register for three years since 2007 and in that time have not produced any persuasive evidence to demonstrate that you have attempted to take such action or gain the necessary insight.

You have exploited vulnerable patients and their families. You have given false hope and made unsubstantiated and exaggerated claims to patients suffering from degenerative and devastating illnesses. Your conduct has unquestionably done lasting harm, if not physically, then mentally and financially, to these patients and also to their families and supporters. It is, therefore, undeniable that you have abused the position of trust afforded to you. You continue to advocate untested and unproved treatments, using your status as a registered doctor to reinforce your personal beliefs.

In addition to considering your extensive clinical misconduct, the Panel has also had to take into account issues relating to your honesty and integrity. The Panel has determined that the actions which led to your police caution were dishonest. Furthermore, your attempts to rectify the situation were wholly insufficient and as a consequence you have demonstrated a lack of integrity and accountability.

Your misconduct is fundamentally incompatible with being a doctor. You have repeatedly demonstrated deep-seated attitudinal problems and a propensity for misleading conduct which is unlikely to be remediable. The Panel is satisfied that, based upon the evidence relating to your clinical practice alone, the sanction of suspension is not sufficient.

Cumulatively, taking into account your dishonest conduct and your clinical deficiencies, the Panel is satisfied that it is necessary, appropriate and proportionate to direct that your name is erased from the Medical Register.
The effect of the direction for erasure is that, unless you exercise your right of appeal, your name will be erased from the register 28 days from today.

Having concluded that your name be erased from the Register, the Panel will now go on to determine whether it considers it necessary for the protection of members of the public, or otherwise, to be in the public interest or in your own interests, to order that your registration be suspended forthwith.

MSRC Statement

On September 29th Dr Robert Trossel was struck off by the GMC.  The decision was based on the grounds of honesty, failure to reach the standards expected of a medical practitioner, being misleading, failure to put the interests of the patients first and being exploitative of vulnerable patients amongst other grounds.

MSRC and New Pathways were horrified when the ACT and Dr Trossel story unfolded to show that both were behaving in unethical and dangerous ways.  When BBC’s Newsnight broadcast an expose on the situation with ACT and Dr Trossel’s use of their products, New Pathways published the entire transcript of the programme in spite of being threatened by ACT with being “taken through every court in the land” should we reproduce the “libel” they claimed it was.  We felt very strongly that the need of the MS Community to know the truth was much greater than our need for legal protection.

We fully support the decision of the GMC

Sources Sky News Copyright ©2010 BskyB, The General Medical Council, The Multiple Sclerosis Resource Centre (29/09/10)

A London-based doctor who exploited "vulnerable" multiple sclerosis patients by exaggerating the benefits of stem cell therapy faces being struck off after his fitness to practise was found to be impaired.

Dr Robert Trossel's actions constituted "repeated and serious breaches" of "many of the essential tenets" of good medical practice, the General Medical Council (GMC) ruled.

Nine men and women, most of whom were suffering from "incurable conditions", visited Dr Trossel, "desperate" to find some relief for their disease and prepared to raise large sums of money to fund treatment.

But the Dutch-trained doctor, 56, used stem cells which were not designed for human use and exaggerated the benefits of treatment based on "anecdotal and aspirational information", according to the GMC's Fitness to Practise Panel.

The panel concluded that his fitness to practise was impaired by reason of misconduct.

Submissions will be made on behalf of the GMC and Dr Trossel on September 27 to allow the panel to decide on sanctions.

Copyright © 2010 The Press Association. All rights reserved. (10/09/10)

Thousands of people are putting their health and life savings at risk to travel to private clinics around the world for unproven and potentially dangerous stem cell treatments, British experts said.

A panel of specialists highlighted individual clinics in Germany and China where so-called "stem cell tourists" go for unlicensed treatment, and said there may be up to 700 similar businesses globally offering unproven cell therapies.

Despite a lack of scientific evidence that such therapies work, patients whose lives are blighted with conditions like Parkinson's disease or childhood blindness are being lured into spending tens of thousands of dollars with little chance of success. "The patient is in danger of losing their life and health, needlessly traveling long distances away from home, friends and family, not having their condition improved, and potentially losing a large sum of money," said Chris Mason of University College London's (UCL) regenerative medicine bioprocessing unit.

The scientists cited one case of an Israeli boy who received a stem cell treatment in Russia for a spinal injury and subsequently developed multiple tumors.

In another case, they said, a 46-year-old woman was treated in Thailand for the autoimmune disease lupus. She later developed kidney failure and died from sepsis.

Stem cells are the body's master cells that give rise to many different tissues and blood cells. They are standard treatments for leukaemias and a few other genetic diseases, but their use in treating other conditions such as Parkinson's, spinal injury or optic nerve damage is as yet unproven.

The International Society for Stem Cell Research has previously warned of rogue stem cell clinics around the world seeking to exploit desperate patients oblivious to the risks.

The British experts said they had been prompted to speak out because of a flood of requests they get from patients who read about apparently dramatic cures on websites and in the media.

They said that while private clinics were not operating illegally, they were offering treatments that are unlicensed and in many cases untested, and advised patients to steer clear.

Treatments can cost around $30,000 a patient, they said, and in the absence of clinical trial data to support their work, clinics post patient testimonies on their websites from people who say they have been helped.

Health authorities in Costa Rica ordered the country's largest stem cell clinic to stop offering treatments in June, saying there was no proof they were effective.

Thailand and Mexico also offer stem cell treatments.

The British experts said they were particularly concerned about a firm in Germany called XCell-Center and a firm in China, Beike Biotechnology, which offers stem cell treatments for a range of conditions including brain injury, cerebral palsy, multiple sclerosis, spinal cord injury and optic nerve damage.

XCell said it would issue a statement on Wednesday about the experts' comments and Beike did not immediately respond to a Reuters request for a response.

"These companies do not offer licensed therapeutics, so it is something the patients themselves have to sign consent forms for," said Peter Coffey of UCL's ophthalmology institute, referring to the two named firms and others like them.

"The main issues around licensing a therapeutic is not just that it's safe... but also to show efficacy. None of these companies has ever been through that type of procedure."

Robert McLaren, a consultant at Moorfields Eye Hospital in London who was also on the panel, said there was "categorically" no evidence to date that stem cell therapies could effectively treat retinal or optic nerve conditions.

"Unfortunately we are dealing with patients who are completely desperate and willing to try anything," he said.

Source: Reuters © Copyright 2010 Thomson Reuters (03/09/10)

Costa Rica has ordered the country's largest stem cell clinic to stop offering treatment, saying there is no proof that it is effective, the country's health minister said on Wednesday.

About 400 patients, mostly foreigners from the United States, have been treated at the Institute of Cellular Medicine in San Jose for multiple sclerosis, arthritis, spinal injuries and other illnesses.

"This isn't allowed in any serious country in the world," Health Minister Maria Luisa Avila said in a telephone interview.

The Health Ministry several weeks ago ordered the clinic, owned by Arizona entrepreneur Neil Riordan, to stop performing the treatment, in which stem cells extracted from the patients are reinjected into their bodies.

The ministry said the clinic has a permit to store the stem cells extracted from patients' own fat tissue, bone marrow and donated umbilical cords but is not authorized to perform the treatment.

Sylvia Molina, an assistant at the clinic, said it would shut its doors on Friday.

Neither Riordan nor the clinic's medical director, Fabio Solano, were immediately available for comment.

Riordan's team uses adult stem cells, which can be found throughout the body.

These master cells of the body give rise to many different tissues and blood cells and are standard treatments for leukemia and a few other genetic diseases.

They are different from embryonic stem cells, taken from human embryos. But Riordan's treatment approach is considered experimental by most experts and the International Society of Stem Cell research has warned against so-called stem cell tourism.

Doctors at Riordan's clinic have said that they have seen excellent results from the procedure, but ministry officials said that there is no proof that the treatments work.

The stem cell treatments at the Costa Rica institute cost between $5,000 and $30,000.

China, Thailand and Mexico also offer stem cell treatments, but Costa Rica's stability, modern tourism infrastructure and proximity to the United States had made it a preferred destination for many patients.

Riordan has a U.S. company called Aidan Products that sells, among other things, a nutritional supplement that his team says can stimulate the body's production of blood stem cells.

He also operates a stem cell clinic in Panama and is chairman of Arizona-based Medistem Inc.

Source: Reuters © Thomson Reuters 2010 (03/06/10)

Robert Trossel used stem cells that were not designed for human use and exaggerated benefits of therapy.

A doctor who exploited a group of "vulnerable" multiple sclerosis patients used stem cells that were not designed for human use, a General Medical Council panel found.

Nine men and women, most suffering from incurable conditions, visited Dr Robert Trossel, "desperate" to find relief for their disease and prepared to raise large sums of money to fund their therapy.

But the panel found Trossel, 55, exaggerated the benefits of treatment which was based on "anecdotal and aspirational information" and "scientific research that had been carried out only on animals".

The Dutch-trained doctor also lacked the necessary knowledge to embark on the therapy, the panel said, while overstating his success rate at treating people with multiple sclerosis.

He also failed to respect the rights of the patients to be fully involved in decisions about their care when they visited him in his clinic in Rotterdam, it said.

At an earlier hearing, Trossel said he only discovered phials sent to him in 2006 by Advanced Cell Therapeutics were not designed for human use when he took part in a BBC Newsnight programme.

A sticker providing information about where the phials came from was later brought to his attention.

Trossel said he looked into California-based All Cells – named on the sticker – and found a disclaimer stating it only produced materials for laboratory use. He said he was told the consignment had been sent in error and was provided by All Cells for research.

Besides his clinic in Rotterdam, Trossel had consulting rooms in New Cavendish Street and Wimpole Street, London.

In October 2006, he was ordered by the Dutch authorities to cease stem cell treatment, the GMC heard.

The panel also heard that the doctor's fitness to practise was impaired because of a conviction in Antwerp last year over stem cell treatment offences under Belgian law. It will resume consideration of the case on September 6.

Source: guardian.co.uk © Guardian News and Media Limited 2010 (13/04/10)

Insufficient safeguards exist to stop desperate patients being exploited by clinics offering unproven stem cell cures, scientists and patients' groups warn as a Harley Street doctor goes before the General Medical Council accused of misconduct.

The doctor, ­Robert Trossel, is accused of sending patients from the UK to his Rotterdam clinic, where for up to £12,000 they could be injected with stem cells to help halt degenerative diseases such as multiple sclerosis. It has been suggested that Trossel's clinic was supplied by another firm, Advanced Cell Therapeutics, which offered to inject 400 booked patients in offshore waters on a ferry.

The charges are that he offered, and made false claims about, treatments with stem cell therapy. Trossel denies the allegations against him.

Stem cell scientists say they fear public confidence in their work risks being undermined by clinics that make false claims. Robin Lovell-Badge, head of stem cell biology at the National Institute for Medical Research, said: "To have charlatans trying … to make money from desperate patients is just terrible for the field."

The Human Tissue Authority, which regulates stem cell use in the UK, inspects licensed clinics to ensure safety and quality. The International Society for Stem Cell Research has issued patient guidelines.

Source: guardian.co.uk  © Guardian News and Media Limited 2010 (11/01/10)

Multiple sclerosis victim Janice Reed thought her prayers had been answered when she read about a pioneering cure that injected sufferers with stem cells.

Advanced Cell Therapy promised a 90 per cent success rate and claimed one wheelchair- bound victim walked again.

But mum-of-two Janice, 47, is £15,000 out of pocket and still needs a walking stick.

And the people behind her treatment in Holland are on the run after being indicted on fraud charges by the FBI.

Janice is one of hundreds who claim ACT bosses Laura Brown and Steve Van Rooyen exploited their desperation.

She said: "I saw no improvement at all. Now I'm sure it was all just a lot of baloney."

Experts have dismissed the 'cure', in which stem cells from umbilical cords are injected to regenerate damaged nerves.

Fines The procedure is illegal in Britain and the US firm who supplied the stem cells say they were meant for research.

Hairdresser Janice, of Aberdeen, was diagnosed in 2000 with MS, which causes the nervous system to degenerate.

She paid Swiss-based ACT £15,000 for stem cell jabs in 2006 and was booked into a Rotterdam clinic run by Preventative Medicine.

Months later, the Dutch health ministry banned PMC from using stem cells over fears they were not fit for human use.

Officials warned patients risked being infected with HIV and hepatitis.

Janice said: "They were taking chances with lives."

ACT bosses Brown and Van Rooyen are wanted by the FBI on 51 fraud charges relating to former company Biomark. They are accused of making false claims about stem cell therapy and face up to 20 years in jail.

FBI assistant attorney Randy Chartash said: "This type of fraud is especially harmful as it victimises people in the most vulnerable situations and individuals who are suffering from an incurable disease."

Brown and Van Rooyen are understood to have fled to South Africa.

No one at ACT was available for comment. PMC said Janice must speak to ACT about a refund.

The firm added: "I'm not sure they are still operative."

The Multiple Sclerosis Society said hundreds of British people have paid ACT for treatment.

They added: "We would never encourage people to take this kind of treatment. We have heard stories about people selling their houses to pay for what are unproven treatments.

"They are desperate and willing to try anything."

Source: SundayMail.co.uk © 2008 owned by or licensed to Scottish Daily Record and Sunday Mail Ltd. (08/06/08)

Stem cell therapy, that has virtually revolutionised the world of medicine in recent years, is now within their reach after the Health Ministry yesterday gave the go-ahead for an Indian hospital, which has done pioneering research in the field, to set up a referral centre in Muscat.

Tie-up

The 'Referral Centre for Advanced Stem Cell Therapy', which will be the first of its kind in the region and the result of a tie-up between Chennai-based Lifeline Hospitals and Al Hayat Polyclinic in Qurum, is expected to start functioning next month.

The arrangement involves Dr J.S. Rajkumar, Chairman of Lifeline Hospitals, visiting Muscat every month for three to four days for consultation at the Al Hayat. He and his team will treat the simple cases here, while the complex ones will be referred to Chennai. Lifeline is one of 10 or 12 stem cell treatment centres in the world and one of two in India.

"There has been a recent focus and extreme interest in the area of stem cell therapies in the field of medicine... What was just a promise a year ago now seems to have a more definitive role in clinical medicine. Evidence for this is streaming in from various parts of the world," Dr Rajkumar said in remarks after discussions with senior Health Ministry officials yesterday.

Clinical trials

Lifeline Hospitals had embarked on clinical trials with autologous (own body derived) stem cells for various critical diseases such as spinal injuries, heart failure and liver cirrhosis a year ago using the latest stem cell technology. The treatment involves harvesting stem cells from the hipbone of the patient and injecting the processed and purified cells back into the spinal fluid. The process called 'autologous stem cell implant' is different from embryonic or cord blood stem cell based therapies.

Lifeline Hospital has completed trials and therapies for more than 100 cases of spinal injuries and also cases with liver cirrhosis and heart failure. "In an analysis of the first 100 cases of spinal injuries who have completed six months follow-up, we have, possibly for the first time in the world, found substantial clinical improvement in 15 cases of which five have shown dramatic 'motor power improvement' — i.e. the patient could either stand up or walk," Dr Rajkumar said.

No side effects

Describing the new technology as ‘regenerative medicine’, he underlined that it did not have any side effects, noting that the therapy used the patient's own stem cells. He said the therapy had proved to be beneficial in the treatment of degenerative disorders like Parkinson's disease and Alzheimer's, certain types of cancers and it could be useful in treating HIV-affected persons.

He cited the case of Akbar Ali, a 21-year old employee of a construction company from the UAE, who fell down from a scaffold and broke his spine. He had near-total paralysis of his limbs and urinary bladder when he started stem cell treatment in Lifeline in December last year. "By February 2007, he could amazingly walk without any support with an easy gait," Dr Rajkumar said.

In another incident, Prabhdeep Singh, a 19-year-old musical performer and part time student from Punjab in India was paralysed waist down after an automobile accident in October 2005. He was on wheelchair when he started treatment in March 2007. By June 2007, "he was progressively improving and is able to stand up and walk with the help of callipers," Dr Rajkumar said.

Not very expensive

Answering a question on costs, he said the treatment "is not very expensive, and ours is one of the cheapest in the world."

The stem cell team, he explained, consisted of a neurosurgeon, bone marrow specialist, anaesthetist and stem cell specialist who performed the therapy. The treatment requires hospitalisation for four days, to be followed by intensive physiotherapy with electrical stimulation.

Source: Khaleej Times Copyright © 2007 Khaleej Times All Rights Reserved.(10/10/07)

The couple, Laura Vanessa Brown and Steven van Rooyen, face a 51 charges of alleged fraud and the distribution of unapproved drugs. But by the time the indictment was issued in March 2006, they'd already fled South Africa. Disagreement over the validity of the nation's extradition treaty has kept the U.S. from bringing them back.

Before leaving the U.S., the couple formed BioMark International and later Advanced Cell Therapeutics, companies that offered doctors an intravenously injected concoction of umbilical cord stem cells. Their patients, who paid $26,000 for treatment, were those with desperate and incurable medical conditions: multiple sclerosis, Lou Gehrig's disease, Parkinson's disease and spinal cord injuries.

The couple say the Bush administration and neurologists have persecuted them for political or profit-driven reasons, and claim that 80 percent of some 800 patients improved. Some stem cell recipients have indeed told tales of unexpected recovery. Others have not been so fortunate; one died shortly after receiving the injections, and a former employee says that patients "would call in all the time saying, 'I can't use my hands, I have a high fever, my doctor doesn't know what it's from.'"

What does it all mean? There's no easy lesson, but the couple are expected to open a clinic in the Seychelle islands, far from U.S. and South African law -- and as stem cell therapies become more sophisticated and more contentious, with patients as desperate as ever to get them, situations like this will probably become more common.

Source: Alleged U.S. Stem Cell Fraudsters Shielded by South African Legal Logjam [ABC News]

BRUSSELS — A private homeopathic clinic in Antwerp has been using stem cells to treat patients with multiple sclerosis and other illnesses, BBC reports.

The use of stem cells, proved to cause cancer, is forbidden in Belgium. Antwerp Prosecutor’s Office have launched an investigation.

Piet Vanthemsche, the head of the Fedreal Health Products Agency, visited the clinic yesterday and said he would keep the prosecutors updated. According to his information, the clinic had indeed broken the law.

The stem cells used in Antwerp came from Rotterdam. The PMC clinic in Rotterdam, headed by Dr. Robert Trossel, had continued their experiments with stem cells, recently outlawed in Holland, by transferring them to Antwerp. Twice a week, PMC ‘s Dr. Aanan took the train the Antwerp carrying his laptop and two containers with stem cells.

The Antwerp clinic had been using stem cells since November 2006. The treatment cost 12,000 euros and involved up to three stem cell injections.

Dr. Trossel would not comment on the subject.

Source: Expatica News Copyright Expatica News 2007

To watch the BBC Newsnight Report please click here

 EXCLUSIVE: PATIENTS' HOPES ARE DASHED

A controversial clinic which offered hopes of a "miracle cure" for multiple sclerosis has been shut down.

The PMC Clinic in Holland was closed after allegations were made that stem cells used in its treatments were not intended for human use.

Scots who had been pinning their hopes on the clinic have been left devastated.

MS patient Tom Forrester had been saving to pay for treatment at PMC.

He tried to kill himself when he found out it had closed.

Tom, 54, of Kirkcaldy, Fife, said: "I had had enough.

"I went to bed on a Saturday night and took 70 painkillers."

Tom was found by carers the following day and spent 10 days in hospital recovering.

The clinic is run by Advanced Cell Therapeutics (ACT).

The Dutch government closed the clinic after ACT were accused of buying stem cells intended for research and using them to treat people instead. It has also been claimed that some of the cells used came from animals.

Many MS patients paid thousands of pounds for stem cell treatment at the clinic after claims that their symptoms could dramatically improve or even disappear.

Such treatment is banned in Britain because doctors are not convinced about how safe or effective it is.

MS patient Amanda Bryson, 20, of Inverness, handed over £12,000 to the clinic in November last year.

After the treatment, she was able to walk again for the first time in a year.

But within months, her symptoms had returned and she was immobilised.

Despite Amanda's experience, many MS patients were counting on the clinic as their only hope of living a normal life.

Margaret Byrne had been on the clinic's waiting list for treatment. She has been wheelchair-bound since 2003. Margaret, 51, of Buckhaven, Fife, said: "I thought I would be walking at Christmas. Now I have nothing to look forward to. I'm devastated."

Between them, Margaret and Tom had raised £14,000 for treatment.

Margaret said: "When the money came in, I thought, great, I'm getting another chance at life.

"We were signing our lives over to the clinic, believing their treatment was legitimate."

The Multiple Sclerosis Trust said there are no other clinics in Europe offering stem cell treatment.

Chief executive Chris Jones said: "We are excited by legitimate research into stem cell treatment. But there's an awful lot of work needed before we can talk about delivering stem cell treatment in a safe, licensed environment."

Storeman Phil Cuthbertson was due to have treatment at the clinic this month after Daily Record readers donated cash.

He has Lebers, a rare genetic condition which has left him blind.

He hoped stem cell therapy would restore his eyesight.

Now he has had to start the process again at another clinic in Holland and faces a three-month wait for treatment.

Phil, 24, of Paisley, said: "I'd been so looking forward to seeing my family opening presents at Christmas."

Phil hopes to have his sight back in time to be best man to his dad Ian, 53, in 10 weeks.

His own wedding is in August, when he will tie the knot with Yvette Bruce, 23.

Phil said: "I'm looking forward to enjoying two big weddings when, hopefully, I'll be able to see."

'I thought I would be walking by Christmas. I'm devastated'

Source: The Daily Record Copywrite 2006 (15/12/06)

The Netherlands Health Care Inspectorate has ordered the Preventief Medisch Centrum (PMC) of Rotterdam to stop performing treatments with stem cells as from today. The Inspectorate concluded that the PMC is not providing responsible care, because it is unable to demonstrate the origin, suitability and safety of the stem cells it uses. This situation jeopardises the health and safety of patients. Among other things, it exposes patients to the risk of infection with HIV or Creutzfeldt-Jacob Disease, (acute) allergic reactions, malignant tumours or rejection reactions.

Last Friday, the Inspectorate received a notification from the Havenziekenhuis hospital in Rotterdam about a patient who had to be admitted with serious complications following stem cell treatment at the PMC. The patient had a serious acute allergic reaction after the administering of stem cells. After being treated with anti-allergy medication at the hospital, the patient was allowed to return home.

Under the Care Institutions (Quality) Act, the PMC is required to provide responsible care. This means care of a good level that is efficient, effective and suitable for the patient. In the case of stem cell treatment, the PMC is obliged to demonstrate through documentation the safety of the entire stem cell supply chain from donor to recipient. To date, the PMC has been unable to present any documentation to the Inspectorate concerning the origin, the suitability for the intended application and the safety of the products that are used.

The order took effect at 17:00 hrs today and will remain in place for one week. The Inspectorate will ask the Minister of Health, Welfare and Sport to renew the order after seven days. The Inspectorate is further considering bringing disciplinary charges against the physicians who work at the PMC.

Source: The Netherlands Health Care Inspectorate (02/10/06)

Multiple Sclerosis patient Alison Atkinson has had her stem cell treatment postponed – days after the screening of a shock TV report.

Alison Atkinson hoped the stem cell injection by Advanced Cell Therapeutics in Rotterdam on Tuesday, September 26, would change her life.

But ACT has told her it has temporarily suspended commercial treatments to engage in clinical trials – following a report on BBC's Newsnight programme which claimed ACT's treatments were using cells not fit for use in humans.

ACT says it has started libel proceedings against the BBC and All Out Productions, who made the programme. The company refused to comment beyond that.

Alison (48 has raised the £13,500 treatment fee with help from friends and an appeal launched in the Lincolnshire Free Press in February.

Alison, of Thary Lane, Surfleet, said: "I am absolutely gutted. But if it is going to be an improvement in treatment then that is fine. I have got to wait and see.

"I think that stem cells are the way forward, not just for MS but for a lot of illnesses."

Alison was among an increasing number of MS patients hoping to improve their quality of life by having an injection of cells taken from the blood of donated umbilical cords.

On Thursday she received an e-mail from ACT which states: "ACT will be engaging in clinical trials for governmental approval over the next two to three months.

"ACT has decided that it would be in the company's best interests to temporarily suspend commercial treatments."

The e-mail says clients such as Alison who have already paid for treatment will be refunded and appealed for people to take part in clinical trials.

Alison has put her name forward.

Source: Spalding Today All rights reserved © 2006 Johnston Press Digital Publishing.

29th August 2006 - BBC Newsnight Programme - The Sale of False Stem Cell Treatments.

You can view the whole programme by clicking here.

Transcript and story below:

Patients warned over dangers of untested stem-cell wonder cures

Patients with crippling diseases such as multiple sclerosis should beware of expensive stem-cell “wonder cures” that have never been properly tested, leading medical research groups say today.

While stem cells offer great promise for treating many disorders, extravagant claims made for therapies costing more than £10,000 a time do not stand up to scientific scrutiny, they say.

In a letter to The Times, 14 medical charities and research funders warn patients that there is no evidence to support the benefits attributed to unorthodox stem-cell treatments, which could carry a risk of infection, immune system rejection and even cancer.

Premature use of stem cells to treat disease, before safety and effectiveness have been evaluated in clinical trials, also threatens to set back mainstream research that promises genuinely better therapies, they say. The signatories include Professor Colin Blakemore, chief executive of the Medical Research Council, Lord Patel, of the UK Stem Cell Bank, and the heads of the MS Society, the Parkinson’s Disease Society, the Juvenile Diabetes Research Foundation and the Alzheimer’s Society.

Stem cells have the capacity to form a wide variety of tissue types, and could be used to replace cells and organs that are damaged or destroyed in conditions such as MS, diabetes and Parkinson’s disease. The most powerful are found in embryos, but other less malleable types can also be extracted from the adult body and from umbilical cord blood.

Only a handful of treatments based on adult and cord blood stem cells have been licensed in the UK, principally for treating leukaemia and eye and skin disorders. But some foreign clinics offer stem-cell injections for other conditions, chiefly MS, and for cosmetic surgery.

Several dozen British MS patients have travelled to a centre in the Netherlands to receive cord blood stem cells from a Swiss company called Advanced Cell Therapeutics (ACT) at a cost of up to £13,500. The Dutch clinic is one of two under investigation by the authorities. The ACT procedure was banned in the Irish Republic this year, prompting the company to consider offering it in international waters on the Swansea to Cork ferry.

While some patients have claimed dramatic improvements and provided glowing testimonials, no scientific evidence has been published showing that the treatment works.

Most mainstream researchers are sceptical that the grafts perform as they are purported to, and ascribe apparent benefits to a short-lived placebo effect.

Scientists are concerned that desperate patients are being exploited. “We advise those who are desperate for cures or attracted to cosmetic surgery to be wary of claims being made by clinics offering these treatments,” the letter says.

An accidental death from a treatment that has not been adequately assessed for safety could also turn public opinion against more carefully regulated stem-cell research. “We worry that those cutting corners risk discrediting the field as well as betraying patients,” the letter says.

Professor Blakemore said that the potential of stem cells would best be realised by cautious progress and rigorous clinical trials. “This is a delicately poised field of research, with a difficult ethical background. Just one application of maverick stem-cell science that leads to cancer could set back the legitimate field by years, if not decades.”

Professor Robin Lovell-Badge, a stem-cell expert of the National Institute for Medical Research, said that there was preliminary evidence that cord blood stem cells could form other kinds of cell, but these did not appear to have a long-term therapeutic effect. It was also hard to see how injecting them could ensure they reached the parts of the body where they were needed.

RISKS ATTACHED TO TREATMENT

• Stem cells are precursor cells that grow into other specialised kinds of tissue
• Those from human embryos are the most malleable and can form any body tissue. Less powerful versions are found in adults’ and umbilical cord blood
• Stem cells of all three types have potential for growing “spare part” tissue to treat conditions such as Parkinson’s, diabetes, MS and spinal injury
• Cord blood and bone marrow stem cells are licensed in Britain to treat leukaemia. Bone marrow is destroyed and replaced with donated stem cells
• Stem-cell therapies have been licensed for use in skin and cornea grafts
• Several foreign clinics offer cord blood stem-cell injections for treating MS and for cosmetic surgery
• There are anecdotal reports of success, but no published clinical trials showing either safety or effectiveness
• Treatment typically costs £10,000 to £13,500 for one injection of about a million stem cells. They are injected into the blood or under skin, not into organs
• Stem-cell therapy has three main risks. The cells have the potential to cause cancers, they can introduce infection, and they can be rejected by the body’s immune system

Source: The Times Online Copyright 2006 Times Newspapers Ltd.

Biomark two finally in court.

They allegedly raked in millions of rands by offering terminally ill and paralysed patients miracle cures.

On Thursday, Stephen van Rooyen and his American girlfriend Laura Brown were involved in a bid in the Kempton Park magistrate's court to stave off an extradition order requested by US Secretary of State Condoleezza Rice.

The couple have been on the run from the FBI for allegedly running an international stem cell scam. Van Rooyen, 44, and Brown, 35, of the upmarket Cape Town suburb of Llandudno, allegedly offered the fake medicine to terminally ill and paralysed patients across the US and Europe.

They made their second appearance on Thursday after their arrest by Interpol at Johannesburg International Airport in June as they returned from Seychelles. They are out on R100 000 bail each.

The hearing got off to a shaky start for the state on Thursday because of the lack of original extradition papers.

According to a treaty signed by South Africa and the US, the papers must be handed in within 60 days of a person's arrest. Thursday was day 61.

However, senior state advocate Beverly Edwards argued that the US government had hand-delivered the extradition papers to the Department of Foreign Affairs on August 1 and that while she did not have an original copy, she had been sent an electronic one.

She said she would be able to have the original document by next week and requested a postponement.

But the couple's high-powered defence team, led by advocate Willie Vermeulen SC, was having none of it.

Vermeulen argued that the onus was on the state to produce the papers timeously.

He told magistrate Steven Holzen that because the state did not have the original extradition papers, he should dismiss the matter.

"The effect of this delay in the interest of fairness and balance... would have a dire effect on my clients. If the state is granted a postponement, the postponement would merely be a prelude to incarcerating my clients. Where is the evidence (original extradition paper)? What is the reason for the delay? It should have been produced a long time ago. The extradition party had more than enough time," he said.

In response, Edwards argued that the absence of the papers was not the fault of the state, and was an administrative delay.

She said the original papers were in the possession of the Department of Foreign Affairs, which was supposed to hand them to the Department of Justice, which then sends them to the Directorate of Public Prosecution before it landed on her desk.

"It is somewhere in this chain. The US is absolutely bona fide. The papers were signed by Condoleezza Rice on July 17. We are well within our 60 days. They were correctly and timeously handed in," she said.

The hearing, which was taking place in court E, had to move to the civil court next door because the prosecutors and magistrates needed the room for an isiZulu lesson.

During this adjournment, Edwards received a phone call to say that the original extradition papers had arrived at the National Prosecuting Authority's offices in Pretoria.

"I have just spoken to a person named Dolly - I don't have a surname - who has said that the documents have arrived," Edwards told the court.

After a brief argument on whether to postpone the hearing to next week, the magistrate decided to postpone the matter until Friday.

A lengthy international investigation by US authorities against the couple culminated in a 51-count indictment handed down by a federal grand jury in Atlanta in March this year.

Van Rooyen and Brown were accused of distributing untested stem cell treatment drugs "without any basis in science".

The couple had allegedly been paid thousands of dollars by individuals suffering with motor neuron disease, multiple sclerosis, and other serious and incurable diseases.

Source: IOL © 2006 Independent Online. All rights strictly reserved.

People with life-threatening illnesses are being swindled out of thousands of pounds by a UK company making offering them false hope, says an expert. Advanced Cell Therapeutics says it can treat people using stem cells taken from umbilical cords.

But stem cell expert Dr Stephen Minger told the BBC there was no way the treatments could work.

Sarah Smith finds it harder on her eyes to use the internet.

Her eyesight is getting worse because of her MS. Two years ago she learned about a company called Advanced Cell Therapeutics on the internet where she read glowing testimonies from other customers.

She was so convinced about unfounded claims that eight out of ten customers saw their conditions improve after being injected with stem cells from umbilical cords, that she paid 9,000 euros to be treated.

She had to travel to their Rotterdam clinic because such injections would not be legal in the UK.

Placebo effect

"I had it done in June and about September time I felt that I might be getting better but in hindsight I think it was the placebo effect.

"I think if you have got the money and it's not going to have a massive change to your life to use that money then go for it, try it but I certainly would not recommend people going into debt for this."

But for Sarah - and many others we have spoken to - the treatment just did not work.

Stem cells are our bodies' remarkable own repair kit, able to develop themselves into other cells within the body.

But one of the country's leading stem cell experts, Dr Stephen Minger of King's College and Guy's Hospital, has told us there is no plausible way ACT's treatment would work.

Dr Stephen Minger said: "This is trafficking in tissues. We take tissues very seriously after Alder Hey, so the idea that this is going on and that this completely unregulated and underground therapy is going on I find disturbing.

"I like to think that people can come and regulate this on an international level."

No medical background

ACT was set up by the one of the founders of a company called Biomark in the US.

This untested treatment was the brainchild of Laura Brown, a media student and former catwalk model from North Carolina and her boyfriend, Steve Van Rooyen, a South African businessman.

And despite no medical background or qualifications they moved to Atlanta and set up Biomark.

They bought the stem cells from labs around North America.

Then, through a network of compliant medical professionals and clinics plus a webpage of flawed and plagiarised testimonies from real experts, they lured sufferers of illnesses like Parkinson's and multiple sclerosis into paying thousands of dollars for treatment, which some of the world's foremost scientists have described as ineffective and possibly dangerous.

Brown and Van Rooyen by this point were making hundreds and thousands of pounds from their flawed "miracle treatment".

Chat rooms and blogs were feverishly alive with the news that Biomark could be the answer to the prayers of sufferers across the US, but back in rural Pennsylvania their claims were to be challenged for the first time.

Nerve deterioration

Nelson Lauver's radio show is syndicated across the US.

He is "The American Storyteller", a chronicler of tales from ordinary lives.

There was nothing ordinary about the story he had to tell, though.

Nelson's brother Craig developed an incurable deterioration of the nervous system, called ALS.

After Craig found out he had the illness, it was a familiar pattern: hours spent on the internet, hopes raised by the dozens of quack remedies on offer only for them to come crashing down when the treatment did not work.

Craig clicked onto the Biomark site to be seduced by the bold but unfounded claims and the testimonies taken out of context, as Brown and Van Rooyen intended. It was just too good to miss.

Craig was told that he to would have to fly to Canada for treatment. As it turned out, he was never well enough to do so.

Home visit

Nelson persuaded someone calling herself Dr Diana Krause from Biomark to turn up at the family home.

But it was not just Craig who was waiting for them. The vase in the corner did not hold just a bunch of flowers and the radio did more than just play out Craig's favourite music.

The room was swarming with electronic bugs.

The family, suspicious of Brown, had contacted the FDA who had the room covered with secret cameras and microphones while agents lay in wait next door.

Nelson Lauver said: "The night before Dr Kraus turned up, I rang Laura Brown and said, 'Hi, I'm Craig's brother and I really want to thank you for this good work and for helping us.'

"She went on about people throwing their wheelchairs away and people who couldn't walk running up and down the steps. It was obvious that this was a scam."

Allowed to go free

The FDA had wired $10,000 from a bogus trucking company they had set up into Nelson's account to pay Biomark using the evidence they had gathered in the sting in Craig Lauver's house.

They then raided Biomark's office.

Although they seized assets of around $250,000, crucially and strangely Laura Brown was allowed to go free.

Brown's whereabouts after the FDA let her go were a mystery, not least to the FBI who in March placed both her and Van Rooyen on their wanted list, issuing a 51-count indictment against them.

Randy Chartash is the FBI's Assistant Attorney in Atlanta, at the courthouse downtown.

In the first interview the FBI have done about Biomark, Mr Chartash told me just how serious these charges against Brown and Van Rooyen are, with the couple facing a very long jail sentence if found guilty.

"The indictment alleges that they made misrepresentations to people about the effectiveness of the stem cell therapy they were offering.

"This type of fraud is especially harmful as it victimises people in the most vulnerable situations and individuals who are suffering or have loved ones who are suffering from an incurable disease.

"They were preying on people at their most vulnerable point."

Stunnning home

It is many months since they were last seen at their apartment, but we have tracked Stephen Van Rooyen down to where he now lives in his native South Africa.

His spacious house perches on top of dramatic cliffs, overlooking the idyllic white sanded beach. This is the area of Cape Town where the beautiful people live.

Van Rooyen has never responded to our letters or emails and no one answered when we knocked on the door.

Like the FBI, we also want to talk to Laura Brown.

She has failed to respond to any of our approaches and we have good reason to think she may be in Pakistan. As a consequence of the FDA letting her slip through their fingers, she was free to set up her fraudulent scheme again, which alarmingly she did here in the UK.

London clinic

But their brand of untested treatment is still being peddled through a London clinic for ACT which sends customers abroad for treatment.

Sarah Smith received her treatment from one doctor, Robert Trossell.

"With all new developments in medicine there are always new groups who are not used to the new concept and they cry like this is impossible.

"They said this of penicillin, insulin and life cell therapy. In the meantime everyone is studying stem cells because everyone knows it is the future."

The Dutch authorities have told us they are investigating the legality of ACT's clinic.

Another centre in Cork is also being investigated by the Irish Medicine Board.

Benefits

One customer we have spoken to who claims real benefit from the treatment is Jan Wilks from Liverpool.

The 45-year-old MS patient claims her condition has improved and she is now able to get about the house without the wheelchair she has relied on.

Scientists are convinced stem cells will eventually be a treatment for previously incurable diseases. Indeed a proper clinical trial on MS patients begins very soon in Canada.

But anything like a miracle advance is, they say, still many years away.

The Stem Cell Swindle will be broadcast on Tuesday, 16 May, 2006 at 8pm on BBC Radio 4.

Source: BBC News Copywrite BBC 2006

Radio 4 - The Stem Cell Swindle.

"The Stem Cell Swindle"

Tuesday 16 May 2006 20:00-20:40 (Radio 4 FM)

Repeated: Sunday 21 May 2006 17:00-17:40 (Radio 4 FM)

Award-winning medical journalist Matthew Hill investigates the people and the companies offering stem cell treatment. He hears from patients who have risked thousands of pounds on the slim chance that stem cells will cure them. Matthew also asks how companies are able to offer this untested and costly treatment in Britain.

www.bbc.co.uk/radio4/factual/pip/v1n47/

03/05/06

A LEADING doctor has called for an urgent legal review of the rules governing international waters after a company offered to provide unlicensed stem cell jabs on board a Welsh ferry.

Dr Dai Lloyd, a Swansea GP and AM for South Wales West, said he feared other private companies could seek to circumvent strict rules governing the use of medicines by offering them on makeshift clinics in the middle of the ocean.

His comments come after it emerged a Swiss-based firm had told its clients it would provide injections of stem cells - a new but unproven treatment for Multiple Sclerosis - on the Swansea-Cork ferry after a doctor in Ireland was forced to stop offering such treatments.

The controversial treatment, which many believe could be a miracle cure for MS, is illegal in the UK and has been suspended in Ireland, following an investigation by the Irish Medicines Board.

Swansea Cork Ferries, which operates the overnight crossing, said yesterday it would not allow any medical procedures to be carried out on board its ships under any circumstances.

It is understood the plan by Advanced Cell Therapeutics (ACT) to use the sanctity of international waters to administer the injections, has now been abandoned.

But Dr Lloyd, a Plaid Cymru AM, said, "This therapy is illegal in the UK and Ireland so it is vitally important that we know what happens in international waters, beyond the jurisdiction of the UK and Ireland.

"It would appear this private pharmaceutical enterprise is riding roughshod over how we licence and make treatments available.

"We know there is a lot of concern about MS but this treatment is being pushed as a miracle cure without the recognised evidence base to back it up.

"If that evidence base was available then presumedly it would be legal in the UK and Ireland and the company would not have to resort to such desperate measures. We need a review of the use of stem cells in MS and a legal review of what can be done in international waters as a matter of urgency."

The controversial stem cell treatment, which comes from umbilical cord blood, costs £12,000 a time and is claimed to repair the spinal damage caused by MS. But many experts are sceptical about the claims, which they say have not been backed up by any trials in the UK.

Dr Richard Lewis, Welsh secretary of the British Medical Association, said, "The BMA cautions both doctors and patients about participating in the provision of care in conditions that are not appropriate for serious medical treatment.

"Innovative procedures in particular must not only be subject to close scrutiny and regulation but should only attempted after appropriate trials and in clinical settings which minimise all risks for patients."

A spokesman for Swansea Cork Ferries last night said, "Swansea Cork Ferries Ltd was astonished to learn that a company was proposing to offer stem cell treatment on board its ship, mv Superferry, while the ship was in international waters.

"The promotion of the treatment which is prohibited under EU law was done without any reference to Swansea Cork Ferries.

"On learning of the proposal, Swansea Cork Ferries contacted the promoters of the treatment and categorically informed them that such treatment was absolutely prohibited on board the vessel.

"The captain and crew captain of mv Superferry have been informed of the company's position and have been instructed to prevent the treatments from taking place should attempts be made to undertake them.

"It is wholly inappropriate that non-emergency medical treatments take place on board passenger ferries and we are appalled that our company was connected in any way with this treatment offer."

Source: icWales copywrite owned by or licensed to Trinity Mirror Plc 2006

01/05/06

• Hundreds of UK patients book £12,000 injections
• Irish Medicines Board acts to stop treatment in Cork

A company offering controversial "stem cell" injections to hundreds of people from the UK with multiple sclerosis and other neurological diseases is planning to get around a ban on treatment in Ireland by carrying it out in international waters on an overnight ferry.

Advanced Cell Therapeutics (ACT), which has an address in Geneva and a London telephone number, has been supplying stem cells from umbilical cord blood to 12 clinics around the world, of which two are in the Netherlands and one in Spain. Demand from the UK - where the treatment is illegal - has been huge, following tabloid newspaper stories about apparent remarkable recoveries and an interview with a clinic doctor on television's Richard and Judy programme.

Scientists, however, dismiss ACT's claims, saying that nobody has yet been able to trick stem cells into repairing the spinal nerve damage that causes MS.

The Guardian recently revealed that ACT has taken over the business of a US company called Biomark International, which closed in 2003 during an investigation by the drugs regulatory agency. Biomark's founders now face a 51-count indictment for allegedly obtaining thousands of dollars by making fraudulent claims about the effectiveness of their treatments.

The Irish Medicines Board has now acted to stop the treatments, costing up to £12,000, that have recently begun at the Cork Road Medical Centre in Carrigaline, which had 400 patients from the UK booked for the coming weeks. In a statement the board confirmed "that it is aware of the stem cell therapy being conducted in the Cork region ... [It is] conducting an investigation into this practice."

But the Guardian has learned that ACT plans to continue treating patients from the UK this week by booking them on to the Cork to Swansea ferry which will take them into international waters, outside Irish jurisdiction. "ACT is offering a convenient alternative, which involves an examination and preliminary consultation at the Cork clinic on the scheduled day of your treatment," it wrote to booked patients. "Administration of stem cell therapy will take place in international waters aboard the ferry. The cost of the return ferry and one night's accommodation will be covered by ACT."

Investigation

It goes on to say that the ferry "is fully handicap accessible and has an array of entertainment on board". It also offers the alternative of treatment in the Rotterdam clinic where most patients from the UK have to date gone for their injections.

The doctor who runs the Cork clinic, John Dunphy, is being investigated by the Irish Medical Council - the doctors' disciplinary body which is the equivalent of the General Medical Council in the UK. Speaking to the Guardian, he said this was routine. "When there is any controversy like this, you usually will be called before them," he said. He denied that he would be treating patients on the ferry, but added: "You will have to speak to ACT. I'm merely facilitating ACT. We are looking for any legal way to treat them." ACT declined to answer the Guardian's questions.

Dr Dunphy said he became involved because his sister has multiple sclerosis and wanted stem cell treatment, but was faced with a long waiting list for the procedure at the Rotterdam clinic. Asked what scientific evidence he had that the treatment worked, he was unable to give specifics, but said: "Obviously I wouldn't be using it if I thought there wasn't any."

The Rotterdam clinic, run by Dr Robert Trossel who is based in London and carries out initial consultations in Harley Street, is also under investigation by the Dutch authorities, the Guardian has learned. The Dutch healthcare inspectorate is concerned that the clinic has not submitted any proposals for its experimental work on humans to ethics committees.

"We are doing this because we have had complaints from Dutch neurologists about the way the doctors are treating the patients," said Karen Donk of the inspectorate. The investigation is expected to be concluded by the end of the summer, she said. It would include inquiries into ACT, the supplier of the stem cells.

The clinic has been allowed to stay open during the investigation because there have been no reports of anybody suffering harm, she said.

In the UK, the Department of Health says that although the government is putting £100m into stem cell research, the science is in its infancy. "We would urge caution against seeking treatment or procedures that have not been subjected to rigorous clinical trials and assessment of safety and potential efficacy. Patients with multiple sclerosis are advised to speak to their consultant about their best treatment options," it said in a statement.

US indictment

The two founders of Biomark International, the US company which used to supply clinics with stem cells and which shared members of its advisory board and patient case histories with ACT, are now facing a 51-count indictment from a federal grand jury in Atlanta.

Stephen van Rooyen, 44, and Laura Brown, 35, are accused of distributing untested stem cell treatment drugs "without any basis in science". US state attorney David Nahmias said in statement that Mr Van Rooyen and Ms Brown "provided false and misleading information" about the effectiveness of stem cell treatment.

"This type of fraud victimises people in the most vulnerable situation," said Mr Nahmias. "The allegations in this indictment are serious and will be prosecuted vigorously."

The US department of justice said it would take steps to bring the two to trial. Mr Van Rooyen has returned to his native Cape Town, while Ms Brown is thought to be in England.

Source: Guardian Unlimited Guardian Unlimited © Guardian Newspapers Limited 2006

26/04/06

A DOCTOR who has used unlicensed stem cell therapy to treat multiple sclerosis patients has claimed he has had to turn hundreds of patients away because of new EU regulations.

Dr John Dunphy, who is under investigation by the Irish Medicines Board (IMB) for providing the treatment at his clinic in Carrigaline, Co Cork, said 400 patients, all from Britain, were due to be seen over the next four weeks.

"All of them had paid for their flights and hotels, and now they must all cancel. There is a major loss financially to people who can ill afford it," he said.

Dr Dunphy had to suspend his use of stem cell therapy a treatment which is not licensed by the Irish Medicines Board since the signing into domestic law on April 7 of new EU regulations.

The GP, who used stem cells supplied by Swiss company Advanced Cell Therapeutics, also claims he is the victim of an orchestrated campaign by British neurosurgeons annoyed at losing patients to him.

In an interview in the Irish Medical Times, Dr Dunphy defended his use of the therapy, used mainly to treat multiple sclerosis and spinal injury.

He said all stem cells he used were:

• Derived exclusively from umbilical cords (no right-to-life issues).
• Donated by informed consent.
• Tested for infectious diseases HIV1, HIV2, Hep B, Hepatitis C, syphilis and CMV (herpes virus).
• Traceable from donor to recipient.
• Used to treat 80 different disease types, with clinical benefits reported in over 80% of patients treated.

He said he had decided to speak out now to expose those conducting what he called a campaign of vilification.

"I presume that senior neurologists in the UK were irritated that their patients were coming to Paddyland for advanced therapy."

He said reports about exorbitant costs €30,000 were "total and complete garbage", adding some patients were charged nothing and others between £1,000 and £5,000 (roughly between €1,400 and €7,200).

Dr Dunphy said that by turning its back on stem cells Ireland was wasting an opportunity.

"This is an extremely important field of medicine. If Ireland does not get involved, we are going to lose out, both from a medical and commercial point of view," said Dr Dunphy.

He added that he has applied to the IMB for a licence to administer stem cell treatment under the new EU regulations.

A spokesperson for the IMB said an investigation into the use of stem cell therapy is ongoing.

Source: The Irish Examiner © Irish Examiner, 2005, Thomas Crosbie Media, TCH

12/04/06

Advanced Cell Therapeutics today issued the following notice of postponement of treatment at their Cork Clinic.

"We are pleased to announce that the Irish Medical Board has invited ACT to comply with the new EU Directive (2004\27\EU) that was transcribed into law on 7 April 2006 (governing all establishments using tissue and cells products).

The ACT executive body has recommended that treatments at the Cork facility be postponed for a short period pending our expedited approval. This is necessary to enable the Cork clinic management and the Irish government to comply fully with the new EU Directive."

It is understood that patients who were booked into the Cork clicnic are being offered alternative arrangements at ACT's Rotterdam Facility.

A Cape Town man and his former model girlfriend are facing a possible 20 years in a US prison for allegedly offering fake medicine to terminally ill patients across the US and Europe.

In a 51-count indictment handed down by a federal grand jury in Atlanta on March 28, Stephen van Rooyen, 44, and Laura Brown, 35, are accused of distributing untested stem cell treatment drugs "without any basis in science".

The couple had allegedly been paid "thousands of dollars by individuals" suffering from multiple sclerosis and other incurable diseases.

US State Attorney David Nahmias said in statement that Van Rooyen and Brown "provided false and misleading information" about the effectiveness of stem cell treatment.

The grand jury's decision to prosecute the couple followed an intensive three-year probe by the FBI and Special Agents of the Food and Drug Administration.

Charges against the duo include fraud and distributing unapproved and misbranded drugs.

The US Department of Justice said they will announce steps later this week in an effort to get the couple to stand trial.

Van Rooyen is believed to be in Cape Town while Brown is thought to be living in England.

The couple had allegedly marketed their products online internationally to desperate patients in several countries including Switzerland, Holland, Germany, Spain, India, Trinidad, Argentina, Brazil, Mexico, Turkey, Saudi Arabia, Pakistan, China and the Ukraine.

Nahmias said the couple's alleged scam posed a grave threat to patients' health. "This type of fraud is especially harmful because it victimises people in the most vulnerable situation," Nahmias said.

"The allegations in this indictment are serious and will be prosecuted vigorously."

The allegations against Van Rooyen and Brown date back to September 2002 when hopeful patients started flocking to clinics and paid thousands of dollars for relief from the supposed miracle cure.

The couple had met in Los Angeles in the late 1990s.

In 2002 they joined an osteopath, Mitchell Chen, in his business in Atlanta.

They learnt for the first time about stem cell treatment when Chen told them about his interest in umbilical cord blood and stem cells.

After a few months, they broke away from Chen and formed a company, Biomark, which soon fell foul with US authorities.

The couple left the US late in 2003 after authorities had raided their offices in Miami.

But their operation appeared to have re-emerged under another name in Europe.

Source: Cape Argus ©2006 Cape Argus & Independent Online (Pty) Ltd. All rights reserved.

© Multiple Sclerosis Resource Centre