India Clears Off-The-Shelf Buerger’s Stem Cell Therapy

Stempeutics Research has been granted limited approval to make and sell the first allogeneic cell therapy product for Buerger’s disease in India. The stem cell therapy, which was granted orphan drug designation by the EMA last year, may hold potential in certain additional indications as well.

Stempeutics Research, which is backed by Cipla Ltd., has received limited approval from the Drugs Controller General of India for manufacturing and marketing its stem cell based biological product, Stempeucel, for Buerger’s disease.

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