Biotech company Regeneus under fire for saying AFL approved stem cell treatment, claims made to patients
BY LOUISE MILLIGAN
A listed company offering stem cell treatments to injured athletes is under fire for talking up the AFL’s “approval” of its procedure and allegedly misleading the stock exchange.
In August, Sydney-based biotech company Regeneus, which raised $12 million by listing on the stock market last year, put out a press release headed “ASX Announcement” which said the AFL “approved” the use of its liposuction-based stem cell procedure for injured players.
But the ABC’s 7.30 program has obtained a letter of complaint written by a group of Australia’s leading stem cell scientists, alleging the company withheld information about its procedure’s efficacy in a price-sensitive announcement to the market.
Sports physician and stem cell researcher Dr Mark Young is concerned about Regeneus’ claims.
“I think we’re all concerned that patients are being given treatments where there’s no evidence of benefit and they’re paying an awful lot of money for it,” he told 7.30.
Regeneus has had much fanfare for its product, which costs $10,000 per treatment.
Its announcement said an independent clinical trial had demonstrated the procedure “reduces pain and halts cartilage degeneration in arthritic joints”.
However, the complaint letter obtained by 7.30 points out the statement left out some key information.
“It is misleading because the control (placebo) group in that trial also achieved the same reduction in pain and slowing of cartilage degeneration,” the letter said.
The control group simply had saline injected into their knees.
Orthopaedic surgeon Dr Justin Roe works at the same clinic as the researchers who conducted the study for Regeneus.
“To not have stem cells harvested and to have something saline put in the joint was just as good as having the stem cells harvested,” Dr Roe said.
“So, in a scientific, evidence-based term, there was no difference between the two.”
Treatment considered safe, allowed by WADA code: Regeneus
Martin Pera, who is Professor of Stem Cell Biology at the University of Melbourne and runs the Australian Research Council’s special initiative on stem cells, applauds Regeneus for funding a proper clinical trial, but wonders why the company cherry-picked the evidence in its statement to the ASX.
“The answer is not to take scientific short cuts in the evaluation of safety and advocacy,” Professor Pera said.
