Stem cell research and therapy, seen as the ?hottest cure? and a major breakthrough in regenerative medical research, appears to have caught the attention of medical researchers, clinicians and the pharma and biotech industry alike in India. For, slowly and steadily, researchers are unraveling new hope for patients battling ailments ranging from heart diseases and diabetes to cancer, specific kinds of blindness and spinal cord injuries.
Early signs are encouraging, with a series of successful clinical trials been carried out at various hospitals in the country, thereby raising India?s claim to be a strong player in stem cell research. In addition, this is a highly interactive field of life sciences and it requires close interaction of basic researchers, clinicians and the industry for the overall growth and development. Guidelines issued by the Indian Council of Medical Research (ICMR) and the department of biotechnology (DBT) on stem cell research have also set forth ethical directions and norms for doing any research and recording of all data in a central place. No wonder, the global market for stem cell research and therapy is expected to be $20-25 billion by 2010. By this period, the Indian market is expected to be worth $600 million with an annual growth rate of 15-20%.
Anoop Misra, director and head, department of diabetes and metabolic diseases, Fortis Hospitals (New Delhi and NOIDA), says, ?Scientists around the world are grappling with the ethical issues surrounding use of stem cells for medical treatment. India has already taken lead in stem cell research and therapy.?
First, a look at the major research leads emerging from the country. At the LV Prasad Eye Institute, Hyderabad, researchers have been successfully taking adult stem cells from the limbus of the eye and using them to reconstruct the damaged outer surface of the eye. In over two years of research and clinical application, the stem cell team has successfully treated more than 750 patients. Apart from transplanting the stem cells tissues in the limbus, several patients have also undergone corneal transplants.
At the All India Institute of Medical Sciences (AIIMS), researchers are perfecting the technology of rebuilding damaged cardiac muscles for patients who have suffered a heart attack. Here again, success has come along the way for researchers who have used stem cells to rebuild damaged muscles for treating patients affected with a cardiac disorder called dilated cardiomyopathy.
Similar efforts, using stem cells for treating cardiac ailments, are being carried out at Christian Medical College (CMC), Vellore. Here, a technology has been established for collection, isolation and purification of haematopoietic stem cells (HSC) for haplo-identical haematopoietic stem cell transplantation. To be more specific, patients suffering from severe anemia have been successfully treated by using stem cell therapy.
Researchers at Manipal Hospital, Bangalore have used stem cells to successfully treat patients for spinal cord injuries. Quite a number of patients have also been treated for Parkinson?s disease too, and with encouraging results. Be it AIIMS, Army Research & Referral Hospital, Delhi, Maulana Azad Medical College, Delhi, Deccan Medical College, Hyderabad, Sanjay Gandhi PGIMS, Lucknow, Narayana Hrudalaya, Bangalore or Sion Hospital, Mumbai, these centres are fast transforming into research hubs for stem cells for the treatment of heart diseases, cancer, spinal injuries and eye defects.
Misra says stem cell therapy is a major breakthrough in regenerative medical research, which is fast catching in India. ?Even as the industry in India being nascent, the potential for it to be a strong player is enormous,? he says, adding, ?it holds a great deal of promise for ?cure? and amelioration of diseases such as diabetes, heart disease, degenerative neurological diseases, certain types of muscle diseases, and rare metabolic disorders. In case stem cell therapy is finally proved to be successful in chronic diseases such as diabetes, it would be an advance bigger than discovery of insulin.?
Stem cells, says Ashok Seth, chairman and chief cardiologist, Max Heart & Vascular Institute (New Delhi) are basic precursor cells, which have the potential to proliferate and develop into any normal tissue cell. They can be obtained from blood, bone marrow, umbilical cord blood when a child is born etc. Their property to regenerate and replace diseased cells with normal cells offers hope for treatment of a number of disabling and life threatening disease processes, which till now, have had no cure.
For example, bone marrow cancers, where diseased blood cells can be replaced by stem cells that grow into normal fresh blood cells; in patients with Parkinson?s disease, spinal cord disease or brain degeneration where diseased and degenerated nerve cells can be replaced by fresh nerve cells; damaged heart muscles after heart attacks leading to heart failure where new heart muscle cells can be reformed thus strengthening the heart muscle; treatment of diabetes and treatment of blindness. ?For me, potential for stem cell therapy is enormous in the years to come,? he adds.
According to Seth, for many of these disorders, no curative treatment options have been available till now. The present treatment methods with drugs or devices only aim at controlling deterioration and achieving partial improvement. In some cases, no treatment options are available. The stem cell therapy provides the hope of replacing diseased tissue with new undiseased tissue. However, lot more research is still being done on?which stem cells should be used, which is the best mode to deliver them into the diseased tissue and how frequently, whether long term benefits are really achieved and whether there are no harmful side effects.
Quite clearly, the medical fraternity sees many reasons for India becoming a strong player in stem cell research. Says Seth, ?Firstly, India has a very large intellectual and scientific pool to encourage biotechnology research. Secondly, given the vast population base and the variety of incurable disease processes, the demand for treatment is high. Thirdly, with a stable and strong economy, India provides opportunities for biotechnology companies; in fact, there are nearly 35 companies now involved in stem cell research/delivery at various stages in India.?
?Fourthly,? he adds, ?unlike many of the western countries where emotional and religious factors are creating obstacles in stem cell research progress ? these factors are not existent in India. In fact, the Indian government is coordinating and partnering excellent ethical and scientific trials in this sphere. Fifthly, stem cell therapy could be available in India at one fifth of the cost than anywhere in the world as has been evident earlier with other advanced treatments like bypass surgery etc.?
Typically, the cost of therapy is quite low when compared to the US. It costs about Rs 1.5 lakh for cornea treatment using stem cells compared to about Rs 7-8 lakh in the developed world.
Interestingly, stem cell banking too is a growing phenomenon in India and around the world.
?A significant number of parents in India are banking their child?s stem cells and the trend is catching up as people realise the importance of storing the stem cells, which is otherwise discarded as a biomedical waste,? says VR Chandramouli, CEO, LifeCell, which has over 8,000 members who have enrolled to store their baby?s umbilical cord blood stem cells.
Stem cells can be harvested and preserved to treat more than 75 serious ailments including neurological disorders and cardiac conditions. ?Over the past years, cord blood stem cells have increasingly been used to successfully treat over 75 diseases and over 10,000 people have been successfully treated with this revolutionary therapy, world over. We foresee numbers going more than double as far as storage is concerned and we expect to store more than 12,000 samples this year.?
In a nutshell, there is an enhanced awareness among the scientists, clinicians and the industry about stem cell research. The process has gained momentum to explore the potential applications of these cells for therapeutic applications.