The Niche

Stem-cell clinical trials set in India

Regulatory authorities in India have, for the first time, given the green light for clinical trials to test stem-cell products, according to an article in Nature Biotechnology. Sponsored by Stempeutics, those trials will test mesenchymal stem cells in patients who with critical limb ischemia or who have had heart attacks. Like a handful of other trials, these cells will be derived from the bone marrow of healthy donors, processed or expanded in vitro, and injected into diseased patients. (See Questioning the Self Cell)

Meanwhile, an unrelated article in the Times of India suggests that, because the US will soon be able to fund more human embryonic stem cell research, India could soon become a hotbed of clinical trials for products derived from these cells. The article includes a quote from the head of a prominent Indian eye clinic stating that most work in India is in non-embryonic stem cells.

Like him, I don’t believe that the Indian market will be flooded with embryonic stem-cell trials anytime soon. Geron is supposed to start trials this summer in spinal cord injury; it needs only a tiny number of patients, with very specific kinds of injuries. Neither Novocell or the London Project will be ready to test their products for, respectively, diabetes or blindness, for several years.

I remember that, at the ISSCR meeting last year, Alok Srivastava, head of the Centre for Stem Cell Research at Christian Medical College, Vellore, described the procedures unregulated clinics in India were performing on paying patients. His argument was that if these clinics could be persuaded to characterize their cells and monitor their patients, the scientific community could glean valuable information. Still, he admitted, such open reporting would usually be at cross-purposes with those trying to make the most money most quickly. (For an analysis of the multiple conflicting motivations in unregulated stem-cell therapies, see our commentary from last year.

Srivastava is on the ISSCR committee that drafted guidelines for conducting clinical research on stem cell products. See Stick to the guidelines and fewer get hurt

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