A company operating out of South Africa is charging tens of thousands of pounds for stem cell treatments, using cells that should not be injected into people, putting the lives of their vulnerable and chronically ill patients at risk, BBC TWO's Newsnight programme has uncovered.
The company, called Advanced Cell Therapeutics (ACT), has been buying cord blood stem cells from California, storing them in the UK as a staging post, then shipping them to clinics in Europe and Africa where doctors inject them into their patients.
ACT claims the cells have a beneficial effect for a host of diseases and conditions from spinal cord injury, lung cancer, deafness and HIV/AIDS. But the majority of their patients come from the UK, seeking help for multiple sclerosis.
Newsnight has spoken to former ACT employees, and established that the two individuals behind the company, Stephen Van Rooyen and Laura Brown, are the same people being pursued by the FBI for an alleged fraudulent stem cell business in the United States, run via a company called Biomark. The pair are living in South Africa, operating under various aliases, and face an extradition hearing by US authorities on 5 September, 2006.
At a clinic in Rotterdam, run by a doctor called Robert Trossel, who administers stem cells on behalf of ACT, Newsnight filmed a vial of cord blood stem cells about to be injected into a two-year old boy. His mother had travelled from Australia under the impression that the treatment might ease the severe after-effects of a meningitis infection in her son, Ethan Regan. The vial was labelled AllCells - a company based in California.
The general manager of AllCells, Jay Tong, told Newsnight he was shocked that his cells were being injected into people. He made clear, as does the company's website, that the cells are intended only for research purposes. They are not guaranteed free from bacterial and viral contamination to the standard that would allow them to be used even in animal models, let alone people. He asked "has anyone died?"
When we put our findings to Dr Trossel, he said: "When confronted with the evidence yesterday, ACT admitted incorrect product delivery on this occasion. We are taking legal action against them and have cancelled all ACT patients until further notice."
Potential health risks
In Cape Town, Newsnight interviewed two former ACT employees, and spoke to Dr Catherine Orridge, who was the medical director of ACT until she became suspicious of the source of the stem cells and found out for herself where they were coming from.
Like Newsnight, she saw the AllCells name on a vial, contacted the company and was devastated to discover that the cells should be used for research purposes only. She is anxious about potential health risks to patients posed by the cells because they contain animal protein. Patients are not told this, so are put at risk of an allergic reaction - including anaphylactic shock, which can be fatal, she says.
AllCells says its cells are intended for research purposes only
Stem cell scientists see enormous potential benefit for medicine from stem cells in the future. But they say it is simply a false hope to use cord blood stem cells in the vast majority of the range of conditions ACT claims.
Professor Colin Blakemore, chief executive of the Medical Research Council told Newsnight:
"I'm shocked. I am taking what you tell me as true, and my first concern is for the patients, very vulnerable, obviously desperate for treatments and that desperation is being exploited by charlatans it seems to me."
Newsnight has also uncovered that the UK has been performing a vital role in ACT's business. A company called CryoStore was holding the frozen stem cells in its Greenwich warehouse.
CryoStore's manager, Malcolm Wilkinson, said in a statement:
"We were advised by ACT that the material was for research purposes. We were not aware of what form this research took."
He said he was seeking advice from the UK's Human Tissue Authority (HTA). When we informed him of the FBI's interest in the individuals behind ACT (known to him as Biomark) he told us he had severed his links with them. He sent ACT's stem cells to another storage facility in the UK and informed the HTA. When we told him our findings he confirmed that that all the material he had held for ACT was from AllCells...
The stem cells are now being stored at Thermo Electron Biorepository Services in Hertfordshire, who say they will probably not continue to store them. They are waiting for written confirmation of what the company in South Africa they've been dealing with, BioCell, has told them verbally - namely that the material is for research purposes only.
"We wouldn't want to condone any unethical treatment," head of operations Robert Jones told us. "Injecting into people would be a clinical purpose, not research."
The HTA said it's done everything it can within the limits of current legislation to advise them about the wisdom of storing cells if they know they are intended for use in people when they are not fit for that purpose.
Newsnight has spoken to Stephen Van Rooyen, who has so far declined our offer of an interview on camera and has not confirmed or denied that ACT's stem cells come from AllCells.
He has pointed out that ACT's patients sign a consent form in which they are told about the risk of an allergic reaction. But that form does not mention animal protein.
When we asked him if his cells come from AllCells, Mr Van Rooyen said:
"I'm sure you understand where I'm coming from here. This is a highly sensitive business, the number of companies around the world that have the technology to produce this kind of cell is very limited and by us going out on the BBC and explaining where our source is is equivalent to commercial suicide. Every single company, individual, doctor, would then be able to go directly to the source."
"In terms of patients having an issue with the safety of the cells and their origin. The most important thing there is that the cells are supported with a certificate of analysis provided to the doctors. The doctors review that. We have a five year track record with not a single negative side effect and the vast majority of people having benefited. That surely matters more than anything. We're not talking about people with minor conditions. We're talking about people who have been sent home to die."
Newsnight contacted Ethan Regan's mother, Sybil, and told her about the origin of the stem cells used in her son's £13,000 injection. She said she was:
"Really disappointed, deceived, duped. What can I say? There are a lot of colourful words I can use but I am not going to. I am really disappointed if the allegations I have heard are true, then it's not fair... the financial perspective doesn't concern me but from a health point of view for Ethan it really does."
Susan Watts' report was shown on Newsnight on Tuesday, 29 August, 2006.