There is no technology other than stem cells that has created such big hype in the medical field in the recent past. There are diverse opinions involving ethical issues in research and therapeutic applications. The ability to reprogram adult stem cells so that they behave like embryonic stem cells has opened up many possibilities in their use for treatment, but in the view of scientists and researchers, a lot still needs to be understood before stem cells can actually be used for potential therapies.

That has not deterred many practitioners from bringing the technology into the clinical domain, especially in countries where either there are no regulations or they are very lax even if they do exist. Most of the time, these practitioners are guided by monetary gains and the desire to be first to bring in new technology rather than an actual desire to benefit their patients. They are also giving in to the demand of patients suffering from chronic, incurable diseases who see this as a ray of hope and wish to give it a try even if scientific proof of efficacy is lacking.

Many patients are willing to travel long distances to places like India, China and other Southeast Asian countries where lawmakers are yet to look into regulating this sector. Lack of legislation in such countries has led to the mushrooming of clinics with dubious claims. In India, the field of biotechnology has seen tremendous growth and has tripled in the last five years. It is projected to grow to achieve a market size of 8 billion USD by the year 2015 according to one report. Stem cell therapy is an emerging sub-segment of the biotechnology industry.

The regulatory authorities in India are blissfully unaware of the risks involved in uncontrolled stem cell therapies. The guidelines and recommendations issued by the Indian Council of Medical Research are essentially an unenforced code of professional conduct and in the absence of supportive law lack a regulatory framework. Still, research in the field being conducted at large hospitals is largely regulated by guidelines set up by ICMR and is properly vetted by medical ethics committees. These hospitals are also using properly authorized stem cell therapies from bone marrow and peripheral blood for limited conditions. The big worry is about unregulated clinical applications being carried out by unauthorized clinics.

At one end of the spectrum are the stem cell banks which are either subsidiaries of their overseas counterparts or run by big business houses. They lure gullible parents into preserving embryonic cord blood stem cells, giving them hope of a cure of unpredictable disease, the chances of which happening is still more unpredictable. On the other end are the clinics luring patients with fraudulent and exaggerated claims of curing chronic neurological ailments. One such doctor, a gynecologist by education, has turned herself into a self-taught stem cell practitioner and claims to have pioneered a technology of using embryonic stem cells for various incurable ailments. Even though her work has never been peer-reviewed, because she never bothered to publish her work, she has supportive testimonials from many patients especially from the US who claim to have benefitted from her treatment.

The use of adipose-derived stem cells is another story. Since they are being harvested and used in the same person, they don’t come under the purview of any law even if they require processing outside the body before being re-injected.