Sydney doctor’s stem cell methods untested by trials

Serious questions have been raised about a stem cell doctor working in Western Sydney who charges $9,000 per procedure and uses methods that are untested by clinical trials.

An investigation by the ABC’s 7.30 program has revealed that Dr Ralph Bright bought his liposuction-based technology from an American company.

The US company is now the subject of a multi-million dollar fraud action, which has revealed the cells being marketed as live were in fact dead.

Dr Bright, of Macquarie Stem Cells, is a former GP and self-taught cosmetic surgeon.

He has been working with stem cells for four years, treating more than 400 patients, including the late model Charlotte Dawson, cricketer Geoff Lawson and Olympic volleyballer Kerri Pottharst.

Dr Bright has licensed his methods to other practitioners around the country and because they use the patients’ own cells he is not regulated by the Therapeutic Goods Administration (TGA).

Stem cells are often hailed as a miracle cure, but the nation’s top stem cell scientists are warning that buyers should beware of these sorts of procedures, which are yet to be subjected to clinical trials.

Professor of Stem Cell Science at the University of Melbourne, Martin Pera, said almost all stem cell therapy was experimental.

“Actually, this whole science of cell therapy is relatively new and it’s very, very important to understand that,” he said.

“When I say experimental, I mean we don’t understand whether it is safe or effective in humans.”

Stem cells being used to treat osteoarthritis

Dr Bright’s stem cells are harvested using the liposuction of fat, then subjected to a process known as ultra-sonic cavitation, which is a high-speed oscillation with a titanium probe.

“A probe goes inside the fat and the sonic shock waves then produce a separation effect which will break the fat cells, which are very fragile, but will not break the stem cells,” Dr Bright said.

The material harvested is then reinjected into the patient, typically for osteoarthritis complaints, although Dr Bright did try it out without success on patients with neurological conditions.

Dr Bright said the patients have had demonstrable decreases in pain.

“When you look at osteoarthritis, all the treatments we have to date destroy the joint, whereas here is a treatment that will actually rebuild the joint,” he said.

“And not only does it rebuild it, it’s using your own body to rebuild yourself, so it is far and away superior medicine.”

Scientists found Intellicell’s method killed stem cells

Dr Bright paid $700,000 to US company Intellicell for a licence for the method.

Intellicell is now being sued by investors and former employees for misuse of funds and alleged fraud because it was discovered that cells it was claiming to be live were dead.

Robert Sexauer was Intellicell’s vice president of Clinical Research and Development and has exposed to 7.30 for the first time what went wrong.

“You cannot take shortcuts, you cannot take any kind of a method whereby you either put patients at risk, or you put the quality of the people that you’re working with in terms of research at risk,” Mr Sexauer said.

In internal company emails in April last year, Mr Sexauer tried to warn management that scientists at four independent universities had found that Intellicell’s method killed the stem cells.

But he said Intellicell chief executive Steven Victor ignored his warnings.

“You’ve got a physician who has been duly notified by highly qualified research institutions that the cellular population that they are using in-human is an inert or dead cell population and they’ve chosen to ignore that and still go on as if it is not and claim to investors, to regulators, to patients, to the communities at large that these cell populations are live cells,” Mr Sexauer said.

The 7.30 program has obtained an affidavit to the US Food and Drug Administrator (FDA) by Intellicell’s quality assurance manager – who first blew the whistle on the company and who said she was “directed … to knowingly adulterate records”.

The manager alleged she was urged to conduct unregistered clinical trials and to create fake data to send to the US Patent Office.

“The pressure to publish was so great and the pressure to publish what I would consider to be less than adequate results was very, very high,” Mr Sexauer said.

“And that is a breach of ethics.”

The affidavit led the FDA to send a formal warning to Intellicell about its methods, which highlighted a number of problems with Intellicell’s laboratory, ranging from quality controls and sanitation to scientific methods.

A group of investor doctors and former employees are now suing Intellicell for misuse of funds and alleged fraud.

Among the litigants is Dr Bright, who had paid for technology that now appeared to be useless.

The plaintiffs have said that Intellicell lied to the US Patent authority and to them.

“[Intellicell] knowingly altered, or caused to be altered, test data and falsely claimed the process provides a 97 per cent live cell recovery … At all times (Intellicell) knew and was aware that the actual recovery of live stem cells was less than 3 per cent,” the court documents allege.

Bright’s modified methods untested scientifically: Sexauer

Dr Bright is still using all the same instruments as Intellicell, but said he had modified the methods.

“We just went back to our basics and said the thing that’s wrong with this is that everything’s being cooked,” he said.

He has now lowered the temperature and left the probe in for less time.

But Mr Sexauer said this new method is completely untested scientifically.

“I’m not aware of anything published whereby those techniques have been held to the scrutiny of peers,” Mr Sexauer said.

“Peers being other research groups, scientists and physicians.”

Also under question is the instrument Dr Bright uses to verify the presence of live stem cells – known as a “flow cytometer”.

Dr Bright said it gave him a “very accurate count of exactly how many cells we have and how many are alive and how many are dead”.

Exactly the same machine was used at Intellicell.

Dr Bright’s cytometer is operated by his wife, a former human resources professional with no scientific training.

By contrast, Vanta Jameson is a PhD in stem cell biology at the University of Melbourne who has worked full-time in flow cytometry for 12 years.

Her machine costs more than 10 times that of Dr Bright’s.

Ms Jameson said the type of machine used by Dr Bright was incapable of accurately distinguishing stem cells from other material.

“It could be 2 million fat cells; it could be 2 million pieces of debris. It could be anything,” Ms Jameson said. 

When asked how he knew he was definitely injecting stem cells back into the patients given he was using this type of flow cytometer, Dr Bright said he once had another research laboratory test them and it gave a positive result.

“We tested all of our cells against 250 different cell markers,” Dr Bright said.

“That’s a task that is far beyond what our little machines here can do.”

When asked by 7.30 whether he checked on a case-by-case basis, he replied that he did not and it was not a practical thing to do in clinical practice.

‘Lots of things could go wrong’

Professor Martin Pera runs the Australian Research Council’s special initiative on stem cells. 

He said the concern was not just about whether these treatments worked, but also whether they were safe for patients, so stem cell practitioners must know what they are doing.

“There are lots of things that could go wrong,” Professor Pera said.

“We could isolate the wrong cell type and put it back in the wrong place.

“We could inadvertently kill the stem cells or contaminate them with bacteria or viruses.

“If our equipment and our reagents aren’t of the highest standard, we could introduce toxic substances into the stem cell preparation.

“And finally, if we grow the stem cells in the lab, they can acquire mutations that would cause them to form cancers in a patient.”

But Dr Bright counters that “all doctors work in uncertainty on a regular basis”.

“Every patient we see, every decision that we make we have to look at the risks and the benefits and then we come to some risk-benefit analysis,” Dr Bright said.

“We never have absolute safety.”

He admitted that he has had adverse events in his patients, including infection and bleeding, and does admit that there is a placebo effect which aids in their recovery.

The constant claim of the Australian therapeutic stem cell industry is that they are using the patients’ own cells – what could possibly go wrong?

Debate over need for a regulator 

In Australia the TGA, the equivalent of the US Food and Drug Administration, does not monitor these procedures.

No independent body is overseeing what is going on.

Dr Bright accepted “absolutely” that this could mean that wrongful behaviour goes unpoliced, but added “much of what we do in medicine is self-policed”.

“Medicine is not set up to be overseen,” he said.

At the other end of the stem cell spectrum lies Professor Silviu Itescu, whose company has spent $500 million on research and clinical trials over the past 10 years to develop a cell line from donor patients, but is still not on the market because it has to be subjected to rigorous clinical trials.

A specialist immunologist, Professor Itescu is concerned the TGA does not police stem cell operators in the way its American counterpart does.

“I think that’s the right bar, it’s the high bar, and it’s what any provider ought to be held accountable to,” Professor Itescu said.

Professor Pera agrees that oversight by a proper regulator is critical to patient safety.

“What’s going on at these clinics may be at the forefront of a major revolution in medicine, or it may be a sham and a fraud and a danger to patients. Again, we simply don’t know,” he said.

“What we do know is that the current framework is allowing human experimentation, medical experiments, on a fairly large scale, with no scientific rigour and no regulatory oversight.

“And is that a concern for a scientific and medical community? It certainly is.”