FDA controls urged for unregulated stem cell treatments

The Food and Drug Administration (FDA) must do more to control clinics offering unproven stem cell treatments in the USA, say scientists.

In an article published in the New England Journal of Medicine, Dr Hermes Taylor-Weiner and Dr Joshua Graff Zivin, both of the University of California, San Diego, claim that hundreds of for-profit clinics charge patients between $5000 and $50,000 for treatments with stem cells. These are offered to patients with conditions ranging from hair loss to heart failure and Parkinson's disease.

The writers warn that the treatments offered by these clinics are neither approved by the FDA, nor supported by clinical studies, and that there may be health risks involved. They express concern that the clinics misrepresent the effects of their treatments, writing: 'Their language is intentionally imprecise and exploits the vulnerability of patients with debilitating diseases.'

It is hoped that stem cells could treat diseases by regenerating dead cells and tissues. However, few treatments involving stem cells have been approved by the FDA, and all those involve the use of haematopoietic stem cells: cells from the bone marrow, which can produce any of the types of cell which are found in the blood.

Most of the therapies on offer at private clinics use stem cells from adipose (fat) tissue, which is collected by liposuction. This is known as stromal vascular fraction (SVF).

The FDA has recently issued draft guidance stating that SVF cells are likely to fall into a category of product that requires strict oversight and official approval for use in patients. It has also issued warning letters and audited some clinics.

However, the authors say these actions are not enough. They suggest that the FDA should enforce the rules by coordinating efforts with state medical boards, revoke the licences of doctors found to be infringing the rules and regulate claims about the effectiveness of treatments.

In a statement given to the Associated Press, Dr Mark Berman of the Cell Surgical Network defended the practices of the clinics: 'There are laws against fraud, and if this weren't a safe and even effective procedure we would have quit doing it long ago.'

However, Dr David Katz of the Yale University Prevention Research Center told Web MD that the public could be in danger of being misled. 'Desperation may breed a particular brand of gullibility, so the patients to whom such clinics cater may be especially vulnerable to what sounds, and in fact is, too good to be true.'