Stempeutics has received consent from DCGI and Indian Council for Medical Research (ICMR) for commencing phase-I and phase-II trials for its Investigational Products to treat conditions of Acute Myocardial Infarction (AMI) and Critical Limb Ischemia (CLI). Investigational Products (IP) are developed from Mesenchymal stem cells derived from bone marrow of healthy donors. IP is specially formulated for intravenous infusion.

The multi-centric, placebo controlled, double blind, allogenic clinical trials will be carried out at hospitals across India to address both the diseases.

Stempeutics established a facility for large scale production of Mesenchymal Stem Cells at Manipal and has produced 200 packs of the same for clinical trials using innovative up- scaling process, BN Manohar, president Stempeutics Research Pvt Ltd told Pharmabiz.

"The phase-I and phase-II will be held over a span of eight months. After which we will proceed for phase III and we are confident that the product launch will around 2011. This will be the first product in stem cells of Indian origin. We have done ample research and in-vitro studies which makes us confident towards our final product, which is based on the successful outcome of clinical studies," he said.

For the product commercialization, the company will be setting up one more laboratory for its large scale production. These stem cells will be sought from healthy donors only.

The company has the competence and the technique in the production of the Mesenchymal stem cell product. It is hopeful that once it is produced it can be marketed at one-sixth of the cost of what is sold abroad. Presently only Osiris Therapeutics Inc (OTI) with its product Prochymal for the treatment of acute myocardial infarction is a proprietary formulation of adult stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation, according to OTI information.

Prochymal is also viewed as a potential treatment for acute Graft vs. Host Disease, an immunity disorder, affecting bone marrow transplant cases. The same drug for Crohn's disease or inflammation of the intestinal tract is in late-stage trials.

Stempeutics, a Manipal Education and Medical Group, will be the first company in India to be ready with the product and possibly the second in the world with this stem cell product. "However, we have the first mover advantage in Malaysia, Singapore and Australia region. We are looking at a cost-effective and affordable therapy to treat scores of patients who are affected with MI and CLI," stated the Stempeutics president.

The company has already commenced its research on diseases like COPD, cirrhosis, and osteoarthritis. Globally the Stem cell product market is expected to be $10 million industry by 2015.

Currently, India has 10 stem cell dedicated companies including Stempeutics and Reliance Life Sciences. The research centres are Centre for Cell and Molecular Biology (CCMB), Hyderabad, LV Prasad Eye Institute, Hyderabad, All India Institute of Medical Sciences, New Delhi CMC, Vellore to name a few.