Stempeutics Research Pvt. Ltd, part of Manipal Education & Medical Group, is investing between Rs. 24 to Rs. 36 crore to open an advanced lab in the Technology Park, Kuala Lumpur. The new initiative, Stempeutics Research Malaysia Sdn Bhd., is expected to promote stem cell research in the region. It will focus on research, therapeutics and therapy in regenerative medicine. The facility which is now getting ready will be inaugurated in January 2008 end and commissioned in March.

This is the first major effort by a foreign stem cell major to set base in Malaysia. The lab has also received a BioNexus status offered by the Malaysia Biotech Corporation which allows financial incentives including tax exemptions, BN Manohar, president, Stempeutics Research told Pharmabiz.

According to Frost & Sullivan, the projected opportunity for stem cells therapies in Malaysia is valued at $157 million. Favourable government polices and the untapped prospects forced us to look at Malaysia, informed the Stempeutics president.

The facility is designed according to US FDA's cGMP (current Good Manufacturing Practices) and cGTP (current Good Tissue Practices) standards. It is also designed to meet the accreditation norms of the Foundation for the Accreditation of Cellular Therapy (FACT) besides adhering to national regulatory and licensing requirements. The lab covers an area of 5,000 sq. ft. and will focus on myocardial infraction(MI), leg ischemia (LI), cerebral stroke, multiple sclerosis, rheumatoid arthritis and type I diabetes research along with experimental autologous stem cells (from one's own body) before it embarks on allogenic (derived from non-related donors) therapies. In the next eight months, the second lab for research on allogenic standard therapies will come up on an area of 25,000 sq. ft.

Meanwhile, its parent company in India, Stempeutics Research has submitted its protocol to the Drugs Controller General of India for allogenic stem cell trials on humans for myocardial infraction and leg ischemia. The trials will be conducted by Manipal AcuNova, the clinical research organization also part of the Manipal Group. The multi centric double blinded randomized trial will have around 80 patients for MI and 100 in LI. The trial data from India will be submitted to the Ministry of Health, Malaysia for permission to conduct fast track trials in the region before the first stem cell product is manufactured and marketed in 2009.

In the first year of operation, 35 people will be inducted of which over 90 percent will constitute local work force and remaining will be from Indian. The strength will be increased to 60 by 2011.

The future expansions will be based on the success of experimental studies and standard therapies. Plans on for a third lab by 2011 to increase its presence in advanced research and development of customized medicine with allogenic stem cells to treat critical disorders with products off the shelf.

The company has also commenced talks for research tie-ups with Malaysia University for both experimental and standard therapies. It is also scouting for entry opportunities to Singapore and Thailand and is scouting for joint ventures with hospitals in the region. Presently, Singapore hospitals are associated with stem cell companies in Israel.