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Stem cell treatment for Buerger’s disease gains limited approval

Stempeutics Research, a group company of Manipal Education & Medical Group and a joint venture with Cipla Group, announced that the Drugs Controller General (India) has granted limited approval for manufacturing and marketing of Stempeutics’ stem cell-based biological product Stempeucel® for the treatment of Buerger’s disease.

Buerger’s disease is a rare and severe disease affecting the blood vessels of the legs. It is characterized by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, leading to severe pain and ulcers or necrosis, which might eventually require amputation. The Stempeucel® treatment is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularization. Stempeucel® is made up of cultured adult allogeneic mesenchymal stromal cells derived by using a novel pooling technology from multiple bone marrow donors. It can be used as an ‘off-the-shelf’ cryopreserved stem cell product.