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First Clinical Trial With Human Stem Cells Approved In India

The Times of India, March 25, 2009

The stem cell company Stempeutics Research has received approval from the Drug Controller General of India (DCGI) to begin the first clinical trial ever to be conducted in India with human stem cells. Specifically, the clinical trial will use mesenchymal stem cells derived from bone marrow in the treatment of two separate conditions, acute myocardial infarction and critical limb ischemia.

According to Nagendra Swamy, the Chief Operating Officer of Manipal Hospital in Bangalore, "It will be a multi-centric placebo-controlled, double blind and allogeneic clinical trial. The aim is to address two diseases: acute myocardial infarction and critical limb ischemia. Since [adult stem cells] derived from a single donor can be manufactured to treat 10,000 patients, we expect the product will provide affordable treatment for all."

The global market for stem cell therapy is projected to reach $20 billion by the year 2010, and currently the stem cell therapy market in India alone is estimated at $540 million.

In addition to myocardial infarction and critical limb ischemia, which is an advanced form of peripheral artery disease, Stempeutics is also currently developing adult stem cell therapies for the treatment of Parkinson's disease, spinal cord injury, motor neuron disease, end-stage liver disease, various skin disorders and avascular necrosis.



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