Stempeutics is on a take off path with its first ever stem cell product Stempeucel ready for Indian market in 2015. The company is currently engaged in developing three products namely Stempeucel, Stempeutron and Stempeucare but experienced a slowdown following the approval of the amendment in clinical trial protocol. Its three products need to go through extensive human studies.

The company noted that it was fortunate as all the ongoing clinical trials were approved before the stalling of the human studies by the Supreme Court ruling in January 2013.

“Indirectly, we were affected, because of an amendment of the clinical trial protocol. However, we are hopeful to launch at least one Stempeucel product for a single clinical indication for the Indian market in 2015. The details of the indication cannot be disclosed now,” BN Manohar, chief executive officer,
Stempeutics told Pharmabiz in an email.

Between 2011 and 2013, number of global clinical trials doubled from 161 to 324. US and China have dominated in the cell therapy trials. Mesenchymal Stromal Cells (MSC) trials surpass all other cell types. Bone marrow is the most common source of MSC followed by umbilical cord and adipose tissue. The first stem cell product was launched in Canada and New Zealand for paediatric steroid resistant GVHD. Korea is marketing two stem cells products: Hearticellgram for Acute Myocardial Infarction and Cartistem for Osteoarthritis of knee joint. “Hopefully, India will also soon launch its first stem cell product in 2015, he added.

India needs to speed up its clearances in human clinical trials and there are only a few dedicated companies focusing on real research and clinical trials. India’s stem cell therapy market is estimated to be around $540 million but expected to grow rapidly. A bottle neck for the sector is availability of skilled manpower and stem cells production infrastructure for large scale upscale of stem cells, he said.

The company’s Stempeutron which is in its beta stage of development will be ready for the market in a couple of months. It is a Point-of-Care, Closed System, Automated Medical Device for Isolation of Stromal Vascular Fraction (SVF) cells from Human Adipose Tissue Lipo-aspirate for Regenerative Medicine. Now SVF can be used for cardiovascular conditions, vascular diseases, wound healing , besides plastic and reconstructive surgery like post mastectomy breast reconstruction, breast augmentation, facial lipoatrophy etc.

Stempeucare is a range of FMCG cosmetic products based on key bioactive factors secreted by the adult stem cells for skin rejuvenation and hair growth applications. The company’s cosmetic product ‘Cutisera’, is developed for wrinkle and fine lines reduction, decrease signs of dermal aging, skin nourishment/rehydration and lightening of dark spots. It has received the regulatory for manufacturing and distribution but is currently undergoing consumer study. The second product under development is for hair growth which indicated positive in vitro efficacy and is ready for human volunteer study.

During the global slowdown of 2008-2013, the stem cells research and therapy decreased in certain areas like the ES cells because of funding issues in US. But other new areas like the iPS cells and MSCs saw exponential growth in the R&D and clinical studies. From 2008 to 2012, stem cell publications doubled from 2.9 per cent CAGR to 7 per cent output, he said.