Stem cell banking and therapy is making its presence felt in the country. About 1,500 people are opting to store their cord blood stem cells every month. As stem cell therapies for diabetes and cardiac disorders await necessary regulatory approvals, industry is expecting to offer treatment to about 165 million people in the next couple of years. Predictably, several players have recently jumped into the fray. Currently, there are 8-10 stem cell banking players in the market which have been increasing capacity and slashing price tags since the beginning of 2009.
Indian healthcare providers are also showing an increased interest for using stem cells-based treatments. All India Institute of Medical Sciences (AIIMS), Fortis Group of Hospitals, LV Prasad Eye Institute, Kokilaben Dhirubhai Ambani Hospital, Mumbai, Amrutha Hospital and Research Institute, Kochi, Manipal Hospital, Bangalore, National Centre for Cell Science, Pune, Sri Ramachandra Medical College in Chennai, among others, are offering stem cell therapy.
Future for this new age therapy looks promising as there is ongoing development of stem cells based treatments for heart attacks in association with various hospitals and medical colleges. There is planned commercial launch of stem cell based drugs in India for heart and limb complications during the next two to three years and. Also, there is ongoing research to explore the potential of using the patient?s own stem cells for curing Parkinson?s disease.
KV Subramaniam, president and CEO, Reliance Life Sciences says, ?In our estimate, by 2011 about 164.4 million patients, suffering from diabetes, cardiovascular disorders, neurological disorders, burns and wounds, osteoarthritis, osteoporosis, bone, cartilage (joints and replacements), liver disorders and congenital abnormalities, would benefit from stem cell therapies in India. Presently, stem cell therapies have good potential in ocular, cardiovascular, and neurological disorders.? According to him, stem cell applications are also emerging as an alternate treatment for multiple sclerosis, muscular dystrophy, Parkinson?s disease, spinal cord injury, strokes, Alzheimer?s disease, rheumatoid arthritis and so on.
In recent months, this new age therapy has seen success at Apollo Hospitals in Chennai. Doctors at the hospital achieved a breakthrough in stem cell treatment for thalassemia, a fatal blood disorder. Thalassemia is among the most common genetic diseases worldwide in which the human body makes an abnormal form of haemoglobin, the protein in red blood cells that carries oxygen. The disorder results in excessive destruction of red blood cells and causes severe anemia that can occur within months after birth. The diseased person has to undergo monthly painful blood transfusion. If left untreated, severe anemia can result in insufficient growth and development, as well as other common physical complications that can lead to a dramatically decreased life-expectancy.
An eight-year-old girl got a successful stem cell transplant at Apollo Hospital, after suffering from thalassemia for six and a half years and undergoing painful blood transfusion every month. Cord blood stem cells from the girl?s brother were injected in the girl and the procedure required no surgery. Since then, several more patients have been treated at the hospital by using cord blood stem cells, informs Mayur Abhaya, president and executive-director of stem cell banking company, LifeCell International.
The breakthrough in stem cell treatment for thalassemia is significant from the fact that every year, 10,000 children with thalassemia are born in India, which constitutes 10% of the total number in the world, and one out of every eight carriers of thalassemia worldwide lives in India, reveals Abhaya. ?Thanks to the breakthrough achieved in stem cell therapy at the Apollo Hospital in Chennai, several life threatening diseases like thalassemia and leukaemia can now be treated completely with no surgery involved,? he adds.
According to Ajit Mahadevan, partner, life sciences advisory services, Ernst & Young, some of the recent developments such as Drug Controller General of India (DCGI) approving the conduct of human clinical trials to develop drugs using stem cells indicate promising future for stem cells banking and treatment in India. Around 75-odd clinical trials too are underway at various hospitals in the country on stem cell therapy.
In recent months, stem cell banking companies have slashed prices of their services to make them popular. For instance, LifeCell International has reduced annual storage cost for cord blood stem cell banking from Rs 79, 000 to Rs 59,900. Couples can also choose to pay an initial fee of Rs 36,000 and store their baby?s cord blood cells at an annual storage fee of Rs 2,000 for 20 years.
According to Subramaniam, India is one of the few countries in the world pursuing stem cell research. But regenerative medicine, comprising stem cell therapies and tissue engineered products, is at a nascent stage in India. A leading player in stem cell research, Reliance Life Sciences has launched the first commercially available autologous limbal stem cell therapy in India, ReliNethra, to benefit the patients suffering from unilateral corneal blindness. The company recently launched ReliHeal?G, (a biopolymeric hydrogel wound management product) which promotes migration of new epidermal cells across the wound surface and is beneficial for early wound healing.
Reliance Life Sciences has also completed clinical trials after regulatory approvals, using mesenchymal stem cells derived from the patient?s own bone marrow for myocardial infarction. The company is carrying out clinical trials for application of stem cell-based therapies for stable vitiligo, non-healing diabetic ulcers, Parkinson?s disease spinal cord injury and autologous stem cell conjuctival graft.
A success story is also emerging from LifeCell International?s stem cell therapy centre at Sri Ramachandra Medical College in Chennai. Encouraged by successful clinical trials on critical limb ischemia, a severe obstruction of the arteries which decreases blood flow to the hands, legs and feet and many a times to amputation of limbs and even death, doctors are getting ready to launch a new therapy using stem cells. ?We carried out clinical trials on 60 patients at Sri Ramachandra Medical College in Chennai and found that 85% of the patients who were recommended for amputation were saved by the therapy. We have applied to the Drug Controller General of India (DCGI) to commercially launch the stem-cell based therapy for critical limb ischemia in India,? says V Ravi Shankar, general manager, LifeCell International.
With over 26 million births being registered every year, India is estimated to be the largest source of umbilical cord blood (source of stem cells) in the world. Going forward, rising healthcare awareness coupled with increasing propensity to pay is expected to play an important role in the growth of stem cell banking and therapy in India. However, healthcare analysts are quick to point out that turning stem cell-based therapies into commercial products require development of scalable manufacturing processes where stem cells are produced under current good manufacturing practices.