Call to close loophole allowing exploitation of stem cell therapies


By Amanda Sheppeard

12 Aug 2016

One of Australia’s leading stem cell experts has called on Australian regulators to block a loophole that is being exploited by rogue ‘stem cell clinics’ to provide unproven and potentially dangerous interventions to desperate patients.

Clinical haematologist and pathologist Professor John Rasko said the TGA’s excluded goods orders was allowing the unregulated use of human cells and tissues when they are “taken from a patient and used under the supervision of a medical practitioner who is caring for that patient for a single indication in a single course of treatment.”

The use of stem cell interventions in patients with osteoarthritis has been a hot topic since the release last month of a NSW coroner’s damning inquest findings into the death of a dementia patient who underwent an unproven liposuction stem-cell procedure.

The findings have prompted calls for a national independent inquiry into the use of autologous stem cell and other unproven procedures.

Professor John Rasko, Professor of Medicine at the University of Sydney, head of the Cell and Molecular Therapies department at the Royal Prince Alfred Hospital, and president-elect of the International Society for Cellular Therapy, said one of the main problems with the practice stemmed from the fact that they were under-regulated.

“At worst this practice presents risks to health,” he told the limbic. “At best it is simply recycling money on something that should not be spent on something that doesn’t work.

“Why spoil a very well established regulatory environment that Australia should be really proud of, aside from this loophole. It must be changed.”

Professor Rasko’s comments follow the publication of paper he co-authored in the international journal Cell Stem Cell, which revealed Australia had one of the world’s highest concentration of direct-to-consumer online stem cell clinics.

“In the early days of this under-regulated industry, clinics were typically located in developing economies, in which weak laws or lax enforcement enabled such businesses to operate with relative impunity,” the authors wrote.

“More recently, richer countries such as Australia, Germany, Italy, Japan, and the United States have seen clinics take advantage of real or imagined gaps in regulation. Consequently, overseas clinics targeting inbound medical travellers now compete directly with those located domestically within major markets.”

The researchers, who were funded by the Cure The Future Foundation, found that Australia had a “very high concentration of stem cell businesses advertising clinical services online”.

“With 19 unique clinic locations offering stem-cell-based interventions for a population of 23.5 million, Australia has a higher number of clinics per capita than the United States, which had the greatest total number of such sites in the world in our search (187 clinics for 310 million people),” they wrote.

They expressed surprise that businesses marketing stem-cell-based interventions were concentrated in countries that tend to have more stringent regulatory infrastructures governing health products and medical practice.

“For example, the Australian government does not consider some autologous cells to be medical products, so licensed physicians are currently relatively unrestricted in their ability to use such cells in medical procedures,” they wrote.

The paper is far from glowing in its conclusions about Australia and other highly developed countries like the US, Ireland and New Zealand when it came to the proliferation of clinics providing unregulated stem cell-based interventions.

“The provision of unproven stem cell-based interventions remains a concerning feature of the clinical landscape,” they concluded.

“We have conducted a census of websites advertising these services directly to consumers and found a number of features confirming those of earlier studies utilizing smaller samples and less exhaustive search strategies.

“Opacity, ambiguity, and lack of disclosure in marketing statements were prevalent in our sample. Vague descriptions of interventions, cell types, and donor sources, and extraordinarily broad, unsupported therapeutic claims were common … The ambiguity of claims made by private companies regarding cell type, cell source, conditions treated, and degrees of regulatory oversight and compliance are a source of concern.”

Professor Rasko told the limbic that while a high proportion of interventions were used for cosmetic purposes, he was deeply concerned about the increasing trend towards the use of stem cells to treat patients with osteoarthritis.

He said stem cells had been trialled for more than a decade for OA without clear evidence of significant benefit.

“These kind of cells simply don’t seem to last or repair large deficits in the joints,” he said. “There is no evidence of a benefit based on stem cell injections, and if the evidence is it doesn’t work, we should be reflecting very carefully on whether we recommend it to patients.”

Professor Rasko said many patients were driven to try stem cell interventions out of desperation and a desire to improve their condition, and he understood this need to seek any opportunity for healing.

“I would love to see a proven cell-based therapy for degenerative joint disease, but at the moment there is not one that has rigorously demonstrated efficacy,” he said.


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