As research into regenerative therapies gains focus across the world, the government has decided to give a booster dose to stem cell-related studies and banking through a regulation. For this, a high-level committee has been formed for monitoring clinical trials and enforcing ethical guidelines.

The committee will have the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of stem cell research, therapy and banking.

Even though India worked out the fundamental guidelines for stem cell research more than two years ago, an effective surveillance system for the highly complex research has to be put in place. The Indian market has now opened up for collaborative projects because of government-authorised trials for stem cell-based therapies.

Without an effective guideline, clinical trials with stem cells may become another money-spinning exercise, warn experts. Currently, a huge amount of research is under way for using stem cells for therapeutic applications like bone regeneration, cartilage regeneration, liver regeneration and cardiac conditions. Research institutes and the private sector have played a pivotal role in intensive research in stem cells and in setting up stem cell banks. However, unlike many highly regulated markets, there are no specific guidelines or regulations in India for corporate or research organisations. Government officials point out that the guidelines for stem cell research and collection, which are based on US/European guidelines, will enable Indian companies to intensify their research and also enable them in gaining access to research funds.

Mayur Abhaya, executive director, Lifecell International, hopes there would be more business opportunities in the days to come as the Indian market is still under-penetrated. Awareness on cord blood banking in India is just 0.1% compared with 3% in the US and 2% in Europe. Like the US, which has a Cord Blood Awareness and Education Act adopted in more than 20 states, there has to be a mandatory law along with a formal education process. ?There has to be government support in the form of funds to increase public banking to fuel stem cell banking,?? Abhaya says. There is limited experience among the medical fraternity though the awareness is slowly improving, he adds.

Meghnath Roy Chowdhary, MD, Cordlife Science India, also feels that the awareness levels among the masses is quite low. ?The regulations have to be implemented in full, which will improve confidence levels among the patient fraternity.?

?With better regulations, the sector can see increased interest from MNCs as well, who will gain confidence to enter the Indian market. Overall, with guideline implementation, the Indian stem cell industry and research will see government support and an increased spur,?? explains Dipta Chaudhury, programme manager – South Asia and Middle East, pharma and biotech practice, Frost & Sullivan.

?The decision of government-authorised trials for stem cell-based therapies comes as no surprise as clinical trials are a necessity to give stem cell therapy its due value and credit. Any stem cell therapy should get prior approval from regulatory authorities like ICMR and DCGI. While conducting case studies, it is imperative to get the hypothesis and concept right. Ultimately, DCGI-approved clinical trial should be the favoured approach to take stem cell research to its rightful culmination,?? says Dr Abhijit Bopardikar, director, Reelabs.

With increasing focus on regenerative medicine, there is a renewed hope for a cure using stem cells for ailments like cancer, diabetes, nervous system disorders and bone and cartilage degenration. Another niche development is dental stem cells. Shailesh Gadre, MD, Stemade Biotech, the country?s first dental stem cell bank, says that dental stem cell can be used to reconstruct bones or generate cardiovascular tissues.

According to available statistics, it is estimated that there are approximately 40 institutes that are pursuing embryonic and adult stem cell research. Incidentally, the regulations would facilitate more partnerships as well. For instance, the Nichi-In Centre for Regenerative Medicine is an Indo-Japan joint venture carrying out research, training and clinical applications-protocol in regenerative medicine, with emphasis on stem cells, progenitor cells and autologous cells to prepare them for clinical application. Moreover, India along with the US, has conducted various workshops on stem cells under the Indo-US Science and Technology Forum.

Estimates peg the stem cell therapies market to touch $100 billion by 2015 from $26 billion in 2006, globally. Hence, a $15-billion business opportunity could come India?s way in the therapies segment alone in the next couple of years and another $5 billion in the research segment during the same time period.