The company's lead product stempeucel® is ex-vivo cultured adult allogeneic mesenchymal stem cells derived by using a novel patented technology from multiple bone marrow donors and can be used as an 'off-the-shelf' cryopreserved stem cell product. A unique cryopreservation solution is used to cryopreserve these cells to attain higher number of viable cells after thawing and without losing their multi-potent differentiation and cytokine production capacity. stempeucel® is currently being tested in several phase II clinical trials for efficacy and safety. Stempeutics expects to launch its first "stempeucel®" cell therapy product for the treatment of Osteoarthritis/Critical Limb Ischemia (OA/CLI) in the market by 2015/16 time period.
The patented production process of "stempeucel®" includes a unique process of multiple cell bank generation from which the Investigational Medicinal Product (IMP) is produced. Unique cell seeding densities are used for the preparation of various cell bank generations. The addition of growth factors to culture media at certain passage has resulted in robust cell yield without compromising the quality of the MSCs. The "master cell bank" or MCB is generated from individual donors comprising of mesenchymal stem cells that are fully characterized and cryopreserved. Next, cryopreserved MCB's are thawed, cultured and expanded for generating a "working cell bank" or WCB. The WCB's are also thoroughly characterized according to our extensive QC criteria prior to cryopreservation. For our IMP, that is stempeucel® production, appropriate numbers of WCB vials are thawed and expanded up to certain passages, harvested and characterized using a variety of parameters necessary to establish the sterility, identity and potency of the product.
Current status of Clinical Trials: All clinical trials are approved by DCGI in India and NPCB in Malaysia
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