From Stempeutics

India's first Human Clinical Trial of Stem Cell-based drug

*Stempeutics received DCGI and ICMR clearance for the company’s Investigational New Drugs (IND) based on mesenchymal stem cells derived from Bone Marrow
*It is a multicentric, placebo controlled, double blind, allogenic clinical trials addressing two diseases i.e. Acute Myocardial Infarction (AMI) and Critical Limb Ischemia (CLI)
*Stempeutics established large scale production of Mesenchymal Stem Cells for Clinical Trials using innovative upscaling process
*Based on the successful outcome of clinical studies plans to introduce the first stem cell based drug -available off the shelf in India by end of 2011.

Stempeutics Research Pvt. Ltd., a group company of Manipal Education & Medical Group announced earlier this week, that Drug Controller General of India (DCGI) has granted clearance of the company's Investigational New Drugs (IND) for conducting clinical trials in patients with Cardio Vascular Diseases which will be the numero uno killer disease by 2020 according to WHO.
Stempeutics will study ID in patients with Acute Myocardial Infarction (AMI) commonly known as Heart Attack and in patients with Critical Limb Ischemia (CLI). Critical limb ischemia is manifested by pain at rest, non healing wounds and gangrene.
Being the first-of- its- kind clinical trial of stem cell based drug in India, it took almost 18 months to get DCGI clearance. Indian Council for Medical Research (ICMR) constituted an expert committee on Stem Cell Research Therapy to examine the proposal and the committee accepted the study as Phase l/ll clinical trials. The DCGI's clearance of IND is one of Stempeutics's significant accomplishments towards its goal of bringing safe, effective and affordable stem cell based drug in India in the near future. India becomes one of the leading countries after USA to enter this phase of Stem Cell research. Till date Stempeutics has filed 7 patents in India and 6 international patents. As on date Stempeutics has established three state of the art labs - two in India and one in Malaysia.
Speaking to media persons, Dr Ranjan Pal, MD &CEO, Manipal Education & Medical Group said "Our mission is to ethically and scientifically explore the full potential of stem cells to transform medicine and offer new hope to millions of people. We believe that Stem Cells would be a major branch of Medical treatment and would be a standard of cure and practice in the years to come. Regenerative medicine is a rapidly emerging area of biomedical research with enormous therapeutic potential world wide, and this would be an ideal supplement for existing medical treatments".
Mr B. N. Manohar, President, Stempeutics Research said, "Stem Cell therapy aims at addressing the root cause of the disease rather than the symptoms. Our goal is to bring out stem cell based drug in the near future using mesenchymal stem cells. We will hit the market with our first product by end of 2011. While the initial foray of Stempeutics is in bone marrow derived mesenchymal stem cells, Stempeutics is investing heavily on its R&D to bring out some innovative products in the near future based on adult stem cells. There will be continuous research for each disease so as to improve product development for effective therapy. Research will be conducted on effective cell number, route of transplantation etc. We want to become an undisputed leader in the Stem Cell area in this part of the world". We have so far invested 50 crores and additional 70 crore will be spent and will look for strategic partners.