Embryonic stem cells (ES) are proving to be a novel pathway to evaluate the effects of chemicals and new drugs in humans. These cells has the potential to hasten the drug discovery process and will also come in handy for the pharma industry to deal with predictive toxicology directly on human stem cells.

According to Dr Ramananda Nadig, consultant, Stempeutics, if this proves to be successful, then the drug discovery time could be brought down by at least 2-4 years. It can hasten the drug discovery process and also pave way for the pharma industry to deal with predictive toxicology directly on human stem cells.

Stempeutics is part of the Manipal Health Systems, engaged in the research and development of human stem cell technology.

"The successful isolation and establishment of human embryonic stem cells can give us genetically stable immortalized human stem cells which are safe for testing new drugs," Dr Nadig said.

The ES-based model of cardiovascular drug development is being successfully used to identify and predict cardio-toxicity on ES cell assay. Embryonic stem cells sourced from embryos which are 4-11 days old can be differentiated to hepatocytes (chief functional cells of the liver), cardiomyocytes (heart cells) and functional neurones (nerve cells) useful in predictive toxicology studies.

While there is difference of opinion on the use of ES for research, the Indian Council of Medical Research (ICMR) is following UK which permits ES for research.

Clinicians and scientists need to scientifically evaluate the benefits of stem cells either as an adjuvant or alternative to the existing forms of therapies. While stem cell therapy is yet to revolutionize medicine, it can offer hope in certain conditions where traditional medicines have proved to be ineffective. There is need to seriously assess the evidence and statistically prove it to practitioners of evidence-based medicine, Dr Nadig said.

A major development in stem cell therapy is the approval for Osiris by US FDA to conduct phase III trials using Allogenic Mesenchymal stem cells. This adult stem cell therapy from the company is expected to bring regenerative medicine with the first products to assist in stem cell treatment. Stempeutics is also working on similar lines to make available Allogeneic stem cell products after it has been evaluated in phase II proof of concept studies, he added.