It seems that stem cells are always surrounded by controversy.
A decade ago the focus was on the ethical issues surrounding embryonic stem cell research, and to the average member of the public this is probably what springs to mind if you said the words ‘controversy’ and ‘stem cells’.
However, there are other issues at hand which deserve a closer look.
In America the Food and Drug Administration (FDA) are seeking an injunction against Colorado Based company Regenerative Sciences LLC and their autologous stem cell application called
Regenexx. The company market their procedure as an alternative for orthopaedic surgery.
The FDA claims that the Regenerative Sciences products are regarded as drugs under the Federal Food, Drug and Cosmetic Act, AND Biological Products under the Public Health Service Act. In response, Regenerative Sciences Medical Director, Christopher Centeno claims that their products are a medical procedure comparable to IVF and therefore outside of the FDA’s jurisdiction.
So the issue for debate between Regenerative Science and the FDA is: should autologous adult stem cells be treated as a ‘biological drug’ or a ‘medical procedure’? Autologous is defined as the patient’s own cells (as opposed to a donors). The debate has been alive and well versed from both camps for a while. Rather than rehash these I’d recommend reading the comments left by Dr Centeno (Regenexx) and Doug Sipp of the RIKEN Centre for Developmental Biology on Sipp’s blog –
Stem Cell Treatment Monitor. All affiliations are openly cited on the blog, and to continue in the same open and honest approach the Australian Stem Cell Centre (ASCC) has employees who are members of the ISSCR.
Some patient forums, such as the
Stem Cell Pioneers, have been supporting the position of Regenerative Sciences and have weighed in on the debate. They feel they are being denied treatment and autologous stem cell therapies should not fall within the FDA’s jurisdiction.
It makes for an interesting and passionate debate. Put simply, over regulation may stifle research, under regulation may put patients at risk.
It could be argued that clinical trials are there for patient’s safety, and that allowing clinicians to self-regulate would put patients at risk. In particular they refer to stem cell companies that offer unproven and experimental therapies and charge patients large sums for them, often referred to as stem cell tourism.
And, it has to be said, some overseas stem cell clinics do take advantage of patients. Offering complete ‘cures’ based on patient testimonials, without discussing risks and possible side effects. Some, if given the benefit of the doubt, are just trying to speed things up and give patients the choice to have experimental therapies. And in the background of all this is the scientists adhering to all the guidelines and running clinical trials.
The ASCC has a
Patient Handbook which explains unproven and experimental therapies, and aims for patients to be able to make well informed, educated decisions regarding their treatment. Whatever that choice may be.
In Australia, human cellular and tissue based therapies or products (biologicals) are regulated by the Therapeutic Goods Administration (TGA) which is the Australian equivalent to the FDA. The TGA has recently developed a new regulatory framework for biologicals. This framework imposes varying levels of regulation on the therapy or product depending on risk, extent of manipulation, and whether the intended use of the biological is its
usual biological function. For example, if a company wanted to gain approval for a treatment that used a biological, and the biologicals intended use was not its normal function, they would have to submit substantial evidence to the TGA that the particular therapy or product is safe, effective and of high quality. More information and detail can be found on the
TGA website.
Read more on the subject:
The FDA
announcement.
Regenerative Science's
press release.
Commentary from
Nature News and
Mass Device.