The Drugs Controller of India has recently cleared Reliance Life Sciences to launch the first
autologous limbal stem cell therapy. Don’t get flummoxed with all the big words, folks! What this means, simply, is that stem cell therapy, for the first time, has been officially cleared for widespread use in India. The same enterprise from corporate honcho Mukesh Ambani’s empire has also set up a cord blood repository — much like the good old blood bank — to store umbilical
Umbilical stem cell banking is passé. Yes, LifeCell International, a private stem cell bank has recently launched a menstrual blood stem cell banking service, aptly titled LifeCell Femme.
Lisa Ray, the petite and exuberant model/actress who recently fought a brave battle against cancer with the help of stem cell therapy, unveiled this innovative service. Now, what is this? Yes, we know how menstrual blood has been discarded as unsanitary waste till now. However, recent research demonstrates that the menstrual blood contains large number of
self-renewing stem cells, demonstrating great potential for cell therapy. More on this later.
The Department of Biotechnology (DBT) has launched over 100 projects at 18 premier institutes across the country to conduct not only basic research on stem cells but also to test its efficacy in therapy.
It has invested over Rs 300 crore, including setting up the first dedicated Institute for Stem Cell Biology and Regenerative Medicine (INSTEM) in Bangalore.
The All India Institute of Medical Sciences (AIIMS) has set up a cardiovascular stem cell group that has begun clinical trials to see whether stem cells could help improve the heart's performance. Another first in the world!
Stem cell treatment could prevent damage to the brain, kidneys and eyes. Many new trials, including a major new £10 million global clinical trial will test whether stem cells can be safely used to treat multiple sclerosis, a autoimmune disease.
Now that we have done our bit on updating you with all the ‘newsy’ bits of information, let’s move on to the basics.
Question: What are Stem Cells?
Answer: The foundation of human life. No, that isn’t a grand statement. It is a scientific fact. What is the human body made of? Trillions of cells. And stem cells, though rare, are the foundation cells for each and every organ and tissue in our body. Yes, their name denotes it — all cells 'stem' from them. Stem cells originally form during fetal development and continue to regenerate tissue throughout a person's life.
Question: What is so special about stem cells?
Answer: They are the body’s biological repair system —albeit hidden. Stem cells have a unique property. When they divide, each of the two new cells has a potential — either to remain a stem cell or become a cell with a more specialised function.
What does this mean? Simple. Stem cells, once divided, can multiply into cells and become cells of the brain, heart, spine, muscles — and everything else that possibly constitutes the human body.
These cells rest once the human body is completely developed. Where? They could be anywhere — in bone marrow, stomach, under the eye or in the skin.
THERAPIES AND THEIR THEORIES:
1. STEM CELLS IN A BOTTLE: READY-TO-USE
Dr Geeta Shroff, a Delhi-based doctor claims to have developed the technology to isolate embryonic stem cells, culture them, prepare them for clinical application and store them in a ready-to-use form with a shelf life of six months. In nine years of clinical application, Shroff has used this technology in over 900 patients to clinically treat everything from a spinal cord injury to diabetes, multiple sclerosis, cardiac conditions as well as cerebral palsy.
Too good to be true?
Well, her clinic has all the requisite certifications vis-à-vis quality and safety management, she follows the guidelines of the ICMR and the entire technology platform has patents applied for. “Theoretically, one cell line can treat the entire human population,” she says, sitting in her clinic packed with patients — adults and children of all colours, race and age; some on wheel chairs, others with crutches, some seemingly healthy.
According to Shroff, this unique cell culture technology makes the cells universally acceptable — without the need for cross-matching. That’s almost like insulin available for diabetics over the counter! “We are working on expansion. On making my technique available as a product,” she says confidently. Can something as complicated as stem cell be as simplified?
“It is my vision to see my therapy available globally as the first line of treatment for many diseases considered incurable. This is the next big thing. This can bring India into the ‘super nation’ league,” she says.
Question: How are stem cells classified?
Answer: On the basis of their origin, three groups of stem cells are recognised:
Human embryonic stem (hES) cells, derived from blastocyst*.
Human somatic stem (hSS) cells, derived from fetal or adult tissues or organs, including umbilical cord blood.
Human embryonic germ (hEG) cells, derived from primordial germ cells of the fetus.
*Blastocyst: Hollow ball of 50-100 cells reached after about 5 days of embryonic development. It consists of a sphere made up of an outer layer of cells, a fluid-filled cavity and a cluster of cells in the interior.
Quick take away: Embryonic and Somatic/Adult stem cells are the common categories Question: What’s so controversial about stem cells?
Answer: Stem cell research holds great promise for improving human health by control of degenerative diseases and restoration of damage to organs by various injuries. But as the Indian Council of Medical Research (ICMR), India’s apex body on biomedical research points out, it also raises several ethical and social issues at the same time. Destruction of human embryos to create human embryonic stem cell lines, potential for introducing commodification in human tissues and organs with inherent barriers of access to socioeconomically deprived — are some such issues. Question: What is stem cell therapy? How are stem cells used? How can they save us? Can they save us?
Answer: Therapies using stem cells are being used to cure everything from diabetes, cardiovascular disorders, neurological disorders, burns and wounds, osteoarthritis, osteoporosis to liver disorders. “We are at the realm of bringing about an era of regenerative medicine", says K. V. Subramaniam, President and CEO, Reliance Life Sciences. According to him, in just two years, about 164 million patients, or 16 per cent of India, would benefit from stem cell therapies in India. That said, scalability of treatments is a big issue.
However, as per ICMR: 1. There is no approved indication for stem cell therapy as a part of routine medical practice, other than
Question: Why is regulation needed?
Answer: The research in this field needs to be regulated to strike a balance. Clearly, stem cell therapies, as of now, are shrouded with mystery and a lack of wide-scale acceptance. There is a need to generate public confidence in the potential benefits of stem cell research as stem cell therapy is poised to enter into clinical practice.
As Vasantha Muthuswamy, Senior Deputy Director General (Retd), Indian Council of Medical Research says, “Yes, there is huge potential in stem cell research and therapy. But in the last 10 years, we haven’t seen anything flattering. It is very important that proper trails are done, protocol is followed, requisite approvals are taken, monitoring and sustained long-term follow ups are done. We are witnessing new developments and that too, at a very past pace. Subsequently, new ethical debates will follow. It is for this reason that the ICMR is in the process of revising its stem cell research and therapy guidelines. The will be released by the end of 2011.”
STEM CELL BANKING: WHAT’S ALL THE NOISE ABOUT?
Bone Marrow Transplantation (BMT) till date. Accordingly, all stem cell therapy other than BMT is treated experimental.
Stem cell therapies are being used across the country to cure:
Corneal regenerative procedures using stem cells are the most promising in India. The L V Prasad Institute has treated over 700 cases with much success. The Drugs Controller has approved of such therapy for widespread use.
Treatment of liver disorders using adult stem cells obtained from bone marrow is growing. The results are promising even in cases of cirrhosis of liver.
India is among the leaders in the world in the treatment of heart disorders using stem cells. AIIMS itself has treated over 100 cases of both acute heart attacks and cardiomyopathy with some success. Multi-clinical trials are now in five institutes to validate the efficacy of stem cell treatment for heart diseases.
Treatment of spinal injuries using stem cell therapy has been encouraging if not spectacular. In Chennai, a study of 280-odd patients found 23 per cent registering improvement.
Treatment of disorders like thalassemia and cancers of the blood is only now gaining a foothold in India. While experts say the potential is good, it is far from being realised.
Source: India Today
The global market for stem cell therapy is projected to increase from an estimated US $30 billion (Rs 1,44,000 crore) in 2009 to US $96 billion (Rs 4,60,800 crore) by 2015.
— Stem Cell Global Foundation
WHAT’S MENSTRUAL STEM CELL BANKING?
The menstrual stem cell comes from the uterine lining (endometrium) that is shed as part of a woman's menstrual period. These menstrual stem cells are "Mesenchymal stem cells" and are unique because they have many properties and characteristics similar to bone marrow stem cells; they multiply rapidly and can differentiate into many other types of stem cells such as neural, cardiac, bone, fat, cartilage and possibly others; demonstrating great promise for future use in clinical regenerative medical therapies. Preliminary research suggests that in addition to potential use by the donor, these stem cells may possibly be used as well to benefit other family members who are genetically related to the donor, such as perhaps a parent, sibling or child.
“The stem cell banking industry is growing at 40 per cent per year”
There are many players in the business of stem cell banking. We spoke to Mayur A, President and Executive Director, LifeCell International.
1. WHO ARE THE PEOPLE OPTING FOR STEM CELL BANKING IN INDIA?
Our target audience for umbilical cord stem cell banking is expectant couples who have over `10 L of household income per annum. This concept is not confined to major cities alone and it is remarkable that we have sizeable number of clients from smaller towns and 2-tier and 3-tier cities also enrolling since they are able to see the future potential in this speciality.
We have 40,000 parents who have preserved their baby’s stem cell samples with us as on date.
2. THERE IS A LOT OF CONTROVERSY AROUND THE VARIOUS STEM CELL THERAPIES? WHAT WOULD BE YOUR COUNTER POINT? IS IT STILL 'EXPERIMENTAL'?
There is no controversy around the concept of umbilical cord stem cell banking and menstrual blood stem cell banking. Bone marrow stem cell transplant has been in practice for over 4 decades in India. Typically hematopoietic cell based therapies are increasing and more work is being done in this area.
With respect to umbilical cord blood stem cells there are various instances where these stem cells were used to treat diseases such as Thalassemia and the clinical outcome has been successful.
With regard to other cell based therapies many clinical trials are under progress and research is exploring newer avenues for cellular applications.
3. NEW DEVELOPMENTS SUCH AS MENSTRUAL STEM CELL BANKING SEEM VERY PROMISING? WHAT ARE YOU FORECASTING? WILL INDIA TAKE TO IT? WHY DO YOU THINK THEY SHOULD?
The menstrual blood is a valuable resource of stem cells. By preserving her own menstrual blood stem cells, one can proactively invest in future health since these stem cells have the future potential to treat certain ailments since stem cells are an invaluable medical resource and stem cell science and clinical applications are fast advancing.
Research on stem cells is advancing every day and many life-threatening and debilitating diseases are coming under the purview of stem cell therapy. While there is no guarantee that the menstrual blood stem cells will ever be of beneficial use, there are a positive indication that many lifestyle disorders could potentially be treated in the future using these stem cells.
4. HOW EXPENSIVE IS STEM CELL BANKING?
The basic service of preserving umbilical cord blood starts at Rs 36,000 and 2,000 per year for the next 20 years. We have also come up with attractive EMI options.
Stem cell research and therapy is in a transition period — from the realm of scientific research to mainstream medical practicing. It is certainly the most critical scientific and technological development on the anvil, with many stakeholders, including government regulatory institutions, medical practitioners and patients. We need to follow stem cell developments closely as they seem to have the answer for all possible ailments of the human body. Will it come through for humanity? We can only wait and watch till the trial period is played out. Remember what happened to all the brouhaha over gene therapy?