The global stem cell market is likely to top $ 20 billion by 2010 according to some estimates. Adult stem cell therapy currently dominates the stem cells market with a share of almost 58 per cent.
The current stem cell therapy market in India is valued at around $540 million. While the opportunity is promising, it is essential that the stem cell treatment becomes less expensive so that it is affordable to common man. It is essential to come out with innovative production techniques to make therapy affordable, said Dr Ranjan Pai, MD & CEO, Manipal Education & Medical Group.
Right now adult stem cells are being used for treatment. These are of two kinds. One is the autologous where stem cells are isolated and processed from one's own blood. The other is allogeneic where stem cells are isolated and processed from a donor. Both these techniques have their advantages and disadvantages.
Diseases which could be treated with stem cell therapies are myocardial infarction, critical limb ischemia, rheumatoid arthritis, stroke, diabetic wound care, age-related macular degeneration, Type I diabetes, diabetes wound to name a few.
With allopathic treatment methods having certain limitations in treating chronic diseases, medical scientists are now dependent on regenerative medicine or stem cell therapy. Medical experts across the globe have explored its benefits for spinal cord injuries, leg ischemia and myocardial infraction. "The Central government should now speed up the implementation of the Stem Cell Policy. In fact, legislation for stem cell usage is a critical component to pursue the next level of research", said Dr. Ramananda Nadig, president and deputy dean, Clinical Research Education and Management Academy (CREMA).
Three sources for human stem cell are human embryos, umbilical cord blood and adult stem cells from bone marrow. There is need to usher in regulation at the earliest to prescribe strict Standard operating procedures for stem cells sourcing from each of these sources, said Dr. Nadig.
There are many medical institutions and research centres which are engaged in stem cell research which makes it indispensable to have a set of regulations in place for good manufacturing practices (GMP), Good Lab Practices (GLP) and Good Tissue Practices (GTP) approval from the authorities.
Currently India has around 10 stem cell dedicated companies including Stempeutics, part of the Manipal Group and Reliance Life Sciences. The research centres include Centre for Cell and Molecular Biology (CCMB), Hyderabad, LV Prasad Eye Institute, Hyderabad, All India Institute of Medical Sciences, New Delhi and CMC Vellore.
There are also companies like Cryo Stemcell ( Kar) Pvt Ltd , LifeCell Chennai and Cryo - Save India in Bangalore, a part of Cryo-Save Group, Europe's largest adult stem cell storage bank engaged in cord blood banking for which the Union government has formulated guidelines for storage only. There are no rules however related to the use of cord blood cells to treat health conditions.
There are only a few cord blood stem cells storage centres in India. Currently, at the Cryo Save India facility , cord blood can be stored by the parents at a fee of Rs 75,000 for a period of 21 years, after which the child who will be an adult will take on the onus to pay an annual fee of Rs 3,000. A world class stem cell banking system is important for a market like India, said VR Chandramouli, managing director, Cyro-Save India.
There is also the 'Stem Cell Voice of India', an NGO to make use of stem cell potential by integrating all the sectors related to this field like scientists, doctors, legal bodies, patients and general public. The project is initiated by Karan Sonny Goel.
Currently, regulatory approvals are sought for stem cells use from the Drugs Control General of India and ICMR . A policy on stem cells will help put an end to the questionable moves of several private institutions to perform stem cell therapy for various illnesses, pointed out Dr Nadig.
The first company to make a big leap into the league of stem cell product developers is Stempeutics, the stem cell arm of the Manipal Health Systems, part of the Manipal Group,.
Stempeutics Research Private Limited (SRPL) has now commenced the clinical trials with its Investigational Products (IP) to treat Acute Myocardial Infarction (AMI) and Critical Limb Ischemia (CLI).The placebo controlled double blind studies are being conducted at five locations in the country at Bangalore, Kochi, Hyderabad, Ahmedabad and New Delhi.
The IP which is being administered intravenously was developed by Stempeutics using the Mesenchymal stem cells sourced from healthy donors. The effort makes it the first company in the country along with a handful of companies globally to aggressively work towards developing the much-awaited maiden stem cell drug.
"Going by positive response on the study which has taken off so far, we are looking at a product launch by early 2011. We have allocated a trial period of eight months for the ongoing phase-I and phase-II after which we will immediately slate the phase-III, BN Manohar," president Stempeutics Research Pvt. Ltd told Pharmabiz.
There is a huge market opportunity with these products. It is estimated that about 35 lakh people suffer from Acute Myocardial Infarction and 10 lakh patients are diagnosed for Critical Limb Ischemia. The Indian market for the mesenchymal stem cells product to treat CLI condition is valued at Rs 250 crore and for AMI it is Rs 500 crore. Globally the stem cell product market is expected to be $10 million industry by 2015, said Manohar.
World wide Osiris Therapeutics, Inc has been working for the last one and half decades to develop and commercialize cellular therapies based on stem cells isolated from readily available adult bone marrow. There are ample scientific evidences to prove that stem cells provide treatments for many disease conditions. US FDA has also permitted the company to conduct phase III trials using allogeneic mesenchymal stem cells.