Clarity on the isolation, delivery and scale-up for production of stem cells together with a lucid understanding on its mechanism are apparent directions which show that, in a couple of years, the stem cell therapy is expected to become a reality, stated Dr Jeff Karp, assistant professor, Harvard Medical School and co-director, Centre for Regenerative Therapeutics, Brigham Hospital.

The stem cell global clinical trials, which is currently estimated at 240, have doubled in the last few years. The positive outcomes in terms of being safe with no reported inflammatory reactions are ample proof that stem cell therapies administered to patients under controlled conditions have proved that it could be the potential therapy option in this decade, Dr Karp told Pharmabiz in an interaction.

Dr Karp, who is also the scientific advisor to Stempeutics and was here in India, said that stem cells are proving to be absolutely safe going by the patients' response and many of the human studies are now in phase III stage. This is a clear indication that by 2015 at least two companies will be offering products off the shelf for treatment.

Currently, there are only a handful of companies which are well positioned in this space. These are Osiris, Mesoblast and Stempeutics to name a few which have the potential to make a global presence going by the research carried out so far. Among the front runner applications are critical limb ischemia (CLI), acute myocardial infarction (AMI), lung diseases, Crohn's disease, diabetes and burns. “Stem cell infusion has proved the disease altering capability. But it would be tough to say anything now if it could reduce cost of treatment. We need a few more years to assess affordability factor,” he said.

The field of stem cells has matured over the last 15-20 years. There are over 1,700 peer reviews published and the number of researchers and medical specialists in the field are increasing, said Dr Karp who is also the principal faculty at the Harvard Stem Cell Institute.

The research focus of Dr Karp is stem cell engineering. Using the mesenchymal stem cells, he has helped to drive innovative engineered solutions to develop the Gecko Medical Adhesive that was recently selected by Popular Mechanics as the ‘Top 20 New Biotech Breakthroughs that would change Medicine.’ The research to develop Gecko Medical Adhesive was funded by NIH and the American Heart Association. “The adhesive is expected to go to human studies in two years. In the proof-of-concept studies, Gecko Medical Adhesive has proved its scope as a patch to stop bleeding and deliver relief in conditions like acute myocardial infarction,” said Dr Karp.