FDA moves to halt unproven stem cell treatments

23 August 2010

Earlier this month the Food and Drug Administration (FDA) sought a legal injunction against a US stem cell clinic to halt their treatments – stem cells that are taken from patients and grown before administration at sites of tissue or bone injury (see Nature news).

This reportedly follows an earlier FDA finding that the Regenerative Sciences clinic treatments were drugs and biological products subject to regulatory approval. However, the clinic argues that the treatments are rather a medical procedure using a patient’s own cells, in the manner of in vitro fertilization, and therefore not a medical product - an interesting distinction.
However, they are on shakier ground when they claim that the safety and efficacy of the technique are adequate and that evidence from clinical trials as required by the FDA is not necessary. Rather, they reportedly claim that adherence to the guidelines of the International Cellular Medicine Society – of which the company chief executive is coincidentally co-founder and medical director – is sufficient.
What form and level of regulation should apply to different types of stem cell therapeutics is clearly still open to debate, but evidence of safety is crucial and any attempts by providers to evade requirements to demonstrate safety is highly questionable. Clinical efficacy is another matter – as for genetic tests, some would argue that evidence of medical benefit should be essential in all cases, whilst others may feel that the principal of caveat emptor (buyer beware) should be sufficient.
The danger is that people desperate for medical help can be misled by the claims made by providers of unproven stem cell treatments. This is potentially more serious than for typical genetic tests, which only provide information about genetic contribution to disease risk. Some stem cell treatments are marketed as potential cures for serious and at present intractable conditions such as neurodegenerative diseases or spinal cord injuries; whilst there is great hope that regenerative medicine may ultimately offer new interventions for such conditions, premature marketing of ineffective treatments is at best unhelpful and at worst, exploitative.
Regenerative Sciences’ website appears to promote treatments as an alternative to surgery for hip, knee or back conditions – so that patients might shun proven medical interventions in favour of unproven ones, which is all very well provided that their choice is a genuinely informed one. The International Society for Stem Cell Research guide for potential customers to help them assess the value of a stem cell treatment (see previous news) is therefore a useful guide.

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