Stem cell therapies are fast emerging as providers of effective cure for varied human disorders. Irrespective of its ethical obligations and negative aspects, the new technology has already offered a big business to the stake-holders.
According to a recent published report , the growth potential of stem cell industry is expected to be over $60 billion by 2015 from an estimated value of US $20 billion projected in 2010. The latest report also suggests that the number of companies engaged in some kind of stem cell research has topped over 100, and about 30-40 of these are actively pursuing stem cell based clinical trials for bringing it to the market in the next 3-5 years.
Major Asian economies are also expected to attract better investments in stem cell industry and India is expected to be in the forefront with a market growth potential with a compound annual growth rate (CAGR) of 25 per cent or more by 2015.
Already the stem cell transplants have become a big time business today. Today India enjoys about two per cent share of stem cell transplant market. At present India is enjoying one of the highest growth rates in stem cell treatments and is already a hub for stem cell work.
The Indian Council of Medical Research (ICMR) has also done tremendous work in the stem cells technology and has brought in remarkable results to devise methodologies to cure bone marrow cancer. Among various researches ICMR’s only stem cell therapy that is effectively tried and tested so far is bone marrow transplantation. Still lot of research is need to be done on the subject as the field is set for tackling neurological, cardiological and reproductive areas of medicine.
In addition to the conventional stem cell transplants of the bone marrow, doctors in India are moving ahead and trying stem cell therapy for the treatment of breast cancer, renal cancer, heart diseases, spinal injury and even neurodegenerative diseases like Parkinson's.
In fact the first stem cell transplant in India was done in the year 1994 at the Tata Cancer Hospital followed by the CMC, Vellore.
AIIMS was the first institute to initiate stem cell therapy research in the year 2005-06 for cardiac failure and other neurological disorders.
As India is already a hub for medical tourism , the country is also slowly turning to a stem cell transplantation hub. With positive results pouring in from research labs, in the near future, India will soon revolutionize the way diseases are treated and it has all the potential to become the stem cell transplantation hub of the world. Already India is renowned for its cost effective medical treatment. The country is known for its high quality affordable medical services and many people from USA, Middle East and other parts of Asia prefer India to avail medical treatment. As per GBI Research report, the stem cell market in India is estimated to touch $ 600 million by 2017
In a recent interview with Pharmabiz , B. N. Manohar, Chairperson, ABLE Committee on Regenerative Medicine, said stem cells hold great promise and potential for both basic sciences and medicine. Stem cells could be a major branch of medical treatment and eventually become a standard of care and practice in a few years. India has made great progress in stem cell research as evidenced by creation of human ES (Embryonic stem) cell lines as well as by publishing more than 100 scientific and clinical papers in various journals.
The field of stem cell biology and regenerative medicine is rapidly moving towards translational research and eventually to clinical practice in India. Since stem cells have the potential to be differentiated into any type of cell, they offer promise for treatments for a wide range of disease conditions. These include damage to the brain, spinal cord, skeletal muscles and the heart. Stem cell therapy is still in clinical trial stage for most of these indications.It could become a standard therapy in the near future, he pointed out.
As the days are passing and more and more results are indicating positive responses of stem cell technology. The hope versus hype over stem cells is perhaps slowly tilting towards a positive direction as the number of clinical trials have increased dramatically over the past 3-4 years.
The scientific progress has been aptly supported by the development of appropriate preclinical animal models to test the stem cell behavior in vivo prior to taking the cells for clinical applications. Both basic and applied stem cell research is gaining pace in India and is now a sizeable commercial industry of significant value.A positive outcome from the ongoing clinical trials could certainly facilitate the approval of these cells for routine clinical use.
At present leading institutes like AIIMS, L.V. Prasad Eye Institute, Center for Stem Cell Research at CMC Vellore and National Centre for Cell Sciences (NCCS) at Pune University are doing intricate research in stem cells.
The major focus of these institutes is on applied part of the research. They are trying to focus on three areas i.e., regeneration of damaged muscles due to heart attack, stroke or cornea damage. Given the prevalence of heart attacks, blindness and strokes, this seems to be a sensible strategy.
The task of these institutes is to locate promising sources of stem cells, apply stem cell therapy to cure patients and verify if the procedure is stable enough for wider application.
However at present there are only about 20 approved stem cell transplantation centres in India. The demand for such centers is growing and at least 2000 more centers of stem cell transplantation are required to meet the requirements of about 50, 000 people who need stem cell transplants per year in India.
Miracles of stem cells
Stem cells are nothing but biological cells found in all multi-cellular organisms that can divide through mitosis and differentiate into diverse specialized cell types and can self-renew to produce more stem cells. In mammals, there are two broad types of stem cells: embryonic stem cells, which are isolated from the inner cell mass of blastocysts, and adult stem cells, which are found in various tissues.
In adult organisms, stem cells and progenitor cells act as a repair system for the body, replenishing adult tissues. In a developing embryo, stem cells can differentiate into all the specialized cells (these are called pluripotent cells), but also maintain the normal turnover of regenerative organs, such as blood, skin, or intestinal tissues. There are three accessible sources of adult stem cells in humans. These include bone-marrow, adipose tissue (lipid cells) and blood.
Results during the past few years have shown that treatment with stem cell promises almost miraculous results and many people have been benefiting from stem cell transplantation especially to cure dreaded diseases like blood cancers. In the year 2010 the famous Canadian actress Lisa Rani Ray who was suffering from blood cancer announced she was cancer-free following a stem cell transplant. Ray had also given a candid interview on her personal cancer trauma and surviving it, which appeared on the cover of the 2010 anniversary issue of the Indian men's luxury magazine ‘The Man’.
Such live instances have given confidence and scientists are enthusiastically working to explore more potentials and capacity of stem cells to successfully cure a myriad of diseases ranging from the common innocuous and non-serious to the most serious, deadly and life threatening diseases has made it as one of the most sought after therapy among Indians.
Global outlook for research
Globally many countries are working to tap the hidden potentials of stem cell that enable effective cure for human diseases. As part of this many countries have funded hugely to carryout stem cell research.
While in the US President Obama has recently announced an increase in government funding for stem cell research, in Asia, South Korea is leading in the stem cell research. The country has a stem cell programme that is now eight years old and has provided close to $150 million to develop stem cell lines that can be used in a variety of therapies.
According to B. N. Manohar, US FDA & EMEA have well defined guidelines for stem cell research and therapy, while it is evolving in South Asia /South East Asia countries. US FDA considers both allogeneic and autologous use of somatic cells as products and need to undergo product development life cycle. A few FDA approved stem cell products are making into the clinics in various parts of the world. Osiris Therapeutics recently announced the approval of its product Prochymal by Canadian regulators to treat children suffering from acute graft-versus-host disease (GVHD), a potentially deadly complication of allogeneic bone marrow transplantation. Osiris also got similar approval in New Zealand for Prochymal.
In 2011, the stem cells market witnessed high growth. More therapies are expected to be launched in the next five years. With the liberalization of stem cell research in the US, many more researchers are inventing in other avenues which could pave way for newer therapies. The stem cell therapy market in the US is projected to be $0.68 billion market in 2012 and $2.1 billion in 2017 growing at a CAGR of 25 per cent ,he added.
Osteocel clocked up to $32 million revenues in 2009. In Korea, Pharmicell has successfully developed ‘Hearticellgram-AMI’ autologous product and received approval from the Korea Federal Drug Agency (KFDA) in July 1, 2011.
Hearticellgram-AMI uses autologous stem cells and is a personalized stem cell therapy product which overcomes immune rejection. Another Korean company, Medipost got approval for their product ‘Cartistem’ in January 2012 from the Korean FDA for the treatment of Osteoarthritis.
With stem cell products being rolled out in various parts of the world, the global stem cell market is poised to grow at a rate of 30 per cent from 2010 to 2012 and projected to be around $ 1.2 billion by 2012 and is expected to reach around $ 16 billion in 2017. North America is likely to post highest value by 2017, he said.
Ethical and social issues
Though stem cell research holds great promise for improving human health by restoring cellular and organ function damaged by degeneration and various injuries, it also raises several scientific, ethical and social issues in the development of such applications.
Apart from challenges of using the right kind of stem cells in the most appropriate way for a particular disease, there are also issues related to the use of human embryos to create human embryonic stem (hES) cell lines, potential for commoditisation of human tissues and cells with inherent danger of exploitation of underprivileged people, and challenges related to prevention of human germ-line engineering and reproductive cloning.
There are also potential dangers of tumourigenicity with use of these cells keeping in view their potential for unlimited proliferation and possible introduction of genomic changes during in-vitro manipulations also limitations related to immunological tissue incompatibility between individuals. Research in this field, therefore, needs to be regulated with special attention to these issues.
Of utmost importance is assurance of safety and rights of those donating embryonic, fetal or adult stem cells for basic and clinical research. Safeguards have to be in place to protect research participants receiving stem cell transplants, and patients at large from receiving unproven stem cell therapies. In recent years societal concern regarding compensation for research related injury has also gained considerable momentum.
All these issues will be addressed by the final 'Guidelines for Stem Cell Research' which the ICMR is expected to be issued soon. After issuing the draft guidelines in March this year, the ICMR is giving final touches to the much-awaited final document which will provide ethical and scientific directions to scientists and clinicians working in the field of stem cell research in the country.