Research on Stem Cells: Policy guidelines needed?

THE DEPARTMENT of Biotechnology, Government of India has set up the National Brain Research Centre(NBRC) near Delhi, which when completed, will be a state-of-the-art R&D Centre to study all aspects of the brain from basic and applied points of view.

Research on the human brain generally has to focus on three fundamental areas, first, understanding the brain from its physiological, anatomical, chemical, biochemical and pharmacological organisational structure and functions, second, study of defects, both natural and acquired, as well as remedies for correcting the defects through therapeutics, surgery or prosthetic devices, and lastly, creating parts of, or eventually, the whole brain, maintaining all their functional attributes. One of the important areas where research would be targetted at the NBRC is related to Stem Cells.

Research on stem cells

The recent hype in this area of research is based on the belief that potentially this is the most promising medical revolution, never thought possible, far exceeding the potential of gene therapy.

According to Nobel Laureate, Harold Varmus, former Director of the National Institute of Health, Bethesda, the development of cell lines which has the potential to create every type of tissue in the human body is an unprecedented breakthrough.

The possibility of replacing the neurons destroyed by stroke, substituting the very traumatic bone marrow cells transplantation with stem cells from donor's blood, rebuilding damaged hearts and muscles, and perhaps, some day, even limbs, and virtually alleviating any disorder which destroys neurons, is real. How did all these developments happen and that too in such a short time? Stem cells are master cells which are capable of producing any of the over 200 cell lines in the human being. In November 1998, two groups of researchers independently isolated stem cells from human embryos and aborted foetuses.

For a long time, even before their isolation, it was believed that only early stem cells or those like in the embryo (upto 4 days), termed totipotent, are totally undifferentiated ie., capable of making any of the body tissues, and those which are termed pluripotent cells are differentiated cells from adults and hence capable of growing only specific organs or tissues.

It was therefore very exciting to find in 1999 that even differentiated cells from the adult could reprogramme themselves to create any tissue earlier thought to be possible only with totipotent cells.

The stark reality of the creation of Dolly from the adult cell proved that it was no longer a hypothesis. The limitations in the use of adult cells is that stem cells from adults have been isolated only for a few of the tissues of the human body.

For example, we are yet to locate adult cardiac or pancreatic islet stem cells in the human. In addition their capacity to proliferate is much less than for embryonic cells.

It has also been established that the adult human brains are also capable of forming new cells, opening up a whole new science of human neurogenesis.

Fred Gage of Salk Institute the leading researcher in the field believes that brain damage of various aetiology is reversible and that if cells can be obtained from the adult brain and grown in- vitro, they can be used for cell replacement and repair in the human brain.

In December 2000, British Scientists demonstrated in mice, that bone cells could be created from undifferentiated stem cells, leading to the possibility of a cure for osteoporosis.

Many chronic ailments, so far managed through palliative therapy may be amenable to cure, using this technology. They encompass Parkinsons, Alzheimers, various Dementias, Diabetes, Osteoporosis, Stroke, Coronary Heart Diseases, Bone Disorders etc., in fact, all diseases which manifest through tissue degeneration or damage.

Both repairs and replacement should become possible in all these areas, once there is a better understanding of determining how to make specific differentiaion by use of appropriate growth factors, anti- oxidants and essential nutrients.

Extrapolating this theme to suggest that Body Repair Kits will be available on the shelves is far fetched, in view of nature's propensity of working through the immune system to reject what it considers as intrusions.

What then is the problem ?

If the evidence for stem cells research is so unambiguous, why then all the recent controversies on the issue? The reasons are only partly technical; they are largely based on moral, legal and commercial considerations.

Many countries in the World have initiated work on stem cells , the leaders are the United States and Great Britain.

It is therefore meaningful to look at the developments in these two countries on policy matters from the stand point of support for stem cell research.

It has been reported that as many as 33 Nobel Laureates have endorsed stem cell research. However, there are many groups which are vehementally opposed. President Bush has denied funding for research from aborted foetuses.

The National Institute of Health drew up a set of guidelines for funding such research by that body. While acknowledging the outstanding potential of this new technology for revolutionising medicine , the NIH concedes that the ethical issues involved deserve due consideration.

The main bone of contention is the source of the cells themselves for research or treatment. Thus , it is advocated that instead of regulations on stem cell research, there could be guidelines on use of human foetal tissues and embryos in transplantation research.

Strongly supported by the British Medical Association, the British Parliament has approved the use of human embryonic stem cells for research.

The human embryos can come from embryos created during in-vitro implantation in fertility clinics.Since Britain has approved therapeutic cloning, creating cloned embryos would be considered legal.

Both in the U.S. and Britain, human stem cell research guidelines will insist on informed consent of the donors concerned. In fact most ethical panels consider that all stem cells used should have been legally derived .

Yet another vexing issue is related to sharing of ownership rights on products from human stem cells, between the donor and the Company which develops them.

What about Patent Rights? Geron Corporation, the leader in research in this area has been licensed several Patents on the utility of human embryonic stem cells by the Wisconsin Alumni Research Foundation (WARF).

The Company has made substantial progress in producing several differentiated cell types, including hepatocytes, cardiomyocytes and dopaminergic neurons, all through appropriately patent- protected technologies.

The biggest challenge in the further progress of this technology, which hopefully will be solved, is that so little is known about the role, specificity and nature of the growth factors needed for production of different types of tissues.

What should be the Indian Approach ?

As already mentioned the newly set up National Brain Research Centre will have many research programmes in the area of human stem cells. In addition, the Indian Council of Medical Research(ICMR) has announced the setting up of at least six Centres for such research during the next five years, for which funds have already been allocated.

At the same time , there has so far been no serious thoughts on an integrated Policy on regulations and guidelines to be followed on this very vital subject. All the issues which have been mentioned earlier , such as sources of embryonic, foetal or adult human cells, their preservation and use, patenting policies on production technology and on products/kits derived from human stem cells, ownership rights, informed consent modalities etc., which have been and continue to be hot topics of debate in U.S.A and Great Britain, are relevant to India.

To dismiss these issues as merely the brainchild of over- reacting anti-abortionists, and human rights activists, is being nalve, since the people of this country are no less conscious and aware of their basic rights than elsewhere.

What is needed is an informed debate threadbare on all these issues and perhaps many more. Then only we can arrive at a meaningful Policy on Research and use of Human Stem Cells.

M.D.Nair

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