Stempeutics Research, a stem cell research company having facilities in India as well as in Malaysia has obtained a Chinese patent (Chinese Application No. CN 201080053627) for its lead product-Stempeucel. The company has obtained patent rights in US as well (US 8956862) for the same technology. Stempeutics Research is the first company in the world to be granted a US process patent for a stem cell medicine based on pooling technology.
The technology pertains mainly to large scale culturing of mesenchymal stem cells for various clinical applications. The mesenchymal stem cells are derived from the bone marrow of multiple donors and are cryopreserved in a unique cryopreservation solution.
Stempeucel is prepared from allogenic bone marrow cells by passing through various cell bank generations. First, a “Master Cell Bank” (MCB) of mesenchymal stem cells is generated from the bone marrow cells followed by further culturing and expansion of the MCB to generate a “Working cell bank” (WCB). The WCB is then expanded up to certain passages, harvested and characterized to generate the final investigational medicinal product (IMP)/Stempeucel.
Stempeucel is currently at different phases of clinical trials in India for different diseases like Critical limb ischemia, Osteoarthritis, Liver cirrhosis and Acute myocardial infarction.
The company is planning to launch its first Stempeucel® commercial product in the market for the treatment of Osteoarthritis/Critical limb ischemia by 2015/16 time period. Eventually, the company aims to target Asian, European and North American markets. The large scale culturing process of Stempeucel should hopefully make the final commercial product affordable to the millions who are in need of such regenerative medicinal drugs.
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