Is a loophole in stem cell law helping new therapy to thrive, or allowing dubious science?

Posted: April 4, 2015 at 12:40 pm

By John ElderApril 5, 2015, 12:15 a.m.

A new frontier in stem cell therapy or a false dawn? John Elder reports.

Last week, Suzie Palmer, 44, travelled from her home in NSW to the Gold Coast for her second round of stem cell treatments for multiple sclerosis. OnTuesday morning,the wheelchair-bound poet underwent liposuction.

By 2.30pm, stem cells had been partially separated from her abdominal fat, suspended in plasma, and injected intravenously. Her doctor, Soraya Felix, is a cosmetic surgeon and molecular biologist with a sideline in regenerative medicine.

Palmer, a relentlessly upbeat and positive person, says the treatments have helped her cope better with heat, improved her mobility and flexibility and otherwise made her "feel like a normal human being". She has, she says, managed a few steps with a walker, still a long way from "running about, which is my dream".

The rapidly growing stem cell industry is aglow with similarly positive testimonials, notably on behalf of practitioners who offer little documented scientific evidence of their success.

Suzie Palmer is literally the poster girl for stem cell tourism within Australia. You can find her smiling sweetly, along with Dr Felix, on the Facebook page of a group called the Adult Stem Cell Foundation. She is one of an unknown number of unwell Australians pinning their hopes on an unregulated industry that is now under review by the Therapeutic Goods Administration.

The TGA public consultation, which closed earlier this month, was prompted by long-standing concerns raised by Stem Cells Australia that a loophole in the regulations has allowed dozens of doctors across Australia to provide experimental treatments without the ethics committee oversight that registered clinical trials are subject to. These treatments invariably cost $10,000 and up. The loophole is this: while the use of donor stem cells in therapies is tightly regulated, the use of a patient's own stem cells is not.

Professor Martin Pera is the program leader of Stem Cells Australia, which is administered by the University of Melbourne and includes scientists from Monash University, the Walter and Eliza Hall Institute for Medical Research, the Florey Institute and the CSIRO, among others. They are engaged in a seven-year Australian Research Council project to answer the big questions about stem cells and the potential for reliable therapies.

Pera's laboratory at Monash University was the second in the world to isolate embryonic stem cells, and the first to describe their differentiation into somatic cells in vitro.

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Is a loophole in stem cell law helping new therapy to thrive, or allowing dubious science?

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