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Advances in science and technology
Few advances in Science and Technology have generated as much controversy as the use of human embryonic stem cells (hESCs) harvested from the pre-implantation embryos. The potential of Stem cells is to replace dead or damaged cells in any tissue of the body. In addition, hESCs offer a new model system for studies on the basic mechanisms of normal and abnormal development biology as also for drug discovery.
The research in this field, therefore, needs to be regulated to strike a balance of utmost importance is assurance of safety, and rights of those donating gametes/ blastocysts/ somatic cells for derivation of stem cells; or fetal tissues/umbilical cord cells/ adult tissue (or cells) for use as stem cells.Safeguards have also to be in place to protect research participants receiving stem cell transplants, and patients at large from unproven
therapies/remedies. With success of growing human embryonic stem cells without feeder layer, derivation of histocompatible hES from embryos created by Somatic Cell Nuclear Transfer (SCNT) and tissue specific differentiation of umbilical cord/bone marrow derived
mesenchymal and haematopoeitic stem cells, there is a need to generatepublic confidence in potential benefit of stem cell research to human health and disease.
Categorization of research on stem cells
According to the source of stem cells and nature of experiments, the research on human stem cells is categorized into following three areas:
Permissible research areas
Restricted research areas
Prohibited research areas
Permissible areas of research are
In-vitro studies on established cell lines from any type of stem cell viz. hES, hEG, hSS; or fetal/adult stem cells may be carried out with notification to IC-SCRT, provided the cell line is registered with the authorized agencies and obtained by GLP.
In-vivo studies in small animals with established cell lines from any type of stem cells viz., hES, hEG, hSS, including differentiated derivatives of these cells, provided such animals are not allowed to breed. This includes preclinical evaluation of efficacy and safety of human stem cell lines or their derivatives.
In-vivo studies on experimental animals (other than primates) using fetal/adult somatic stem cells from bone marrow, peripheral blood, umbilical cord blood, skin, umbilical cells, dental cells, bone cells, cartilage cells or any other organ (including placenta), provided appropriate consent is obtained from the donor .
Clinical use is not permitted
Until the efficacy and safety of the procedure is established the origin, safety and composition of the product is adequately defined and labeled.Conditions for storage and use is given in detail. Release form and infusion formalities are required as for
blood transfusion with long term follow-up.levels of manipulations (processing) are categorized as givenbelow. minimal manipulation - no major alterations in cell
population or alterations of function (use of antibodies,cytokines etc).Moderate manipulation - defined alterations in cell population (T cell depletion, cancer cell depletion),expansion etc.
major manipulation - such as genetic alteration by insertion of gene/siRNA etc.
Restricted areas of research
Creation of a human zygote by InVitroFertilization or any other method with the specific aim of deriving a stem cell line for any purpose. It would be required to establish that creation of zygote is critical and essential for the proposed research. Informed consent procedure for donation of ova, sperm, somatic cell or other cell types as detailed by scientific guidelines.
If there is a possibility that human cells could contribute in a major way to the development of brain or gonads of the recipient animal, the scientific justification for the experiments must be
strong. The animals derived from these experiments shall not be allowed to breed.
Prohibited areas of research
Any research related to human germ line genetic engineering or reproductive cloning.
Any in-vitro culture of intact human embryo, regardless of the method of its derivation, beyond 14 days or formation of primitive streak, whichever is earlier. Transfer of human blastocysts generated by parthenogenetic or androgenetic techniques into a human or nonhuman uterus. Any research involving implantation of human embryo into uterus
after in-vitro manipulation, at any stage of development in human / primates.
Responsibility of investigators and institutions
The investigators and the institutions where the stem cell research is being conducted bear the ultimate responsibility of ensuring that research activities are in accordance with laid down standards and integrity. In particular, scientists whose research involves Stem cells
should work closely with monitoring/regulatory bodies, demonstrate respect for autonomy and privacy of those who donate gametes, blastocysts, embryos or somatic cells for SCNT, and be sensitive to public concerns about research that involves human embryos.
Each institution should maintain a registry of its investigators who are conducting hES cell research and ensure that all registered users are kept up to date with changes in guidelines and regulations regarding use of hES cells.
Each institution shall constitute an advisory committee and provide adequate support for its functioning or ensure that its team has adequate expertise to handle proposals related to
research with stem cells. All records pertaining to adult stem cell research must be maintained for at least 5 years and those for hES cell research for 10 years.
Stem cells have immense potential for cell-based (transplantation)therapy, following lineage-specific differentiation, for various human diseases such as diabetes mellitus, myocardial infarction, Parkinson's disease, etc. In recent years, there have been attempts to use somatic stem cells (from the bone marrow, umbilical cord) for cell therapy for the above diseases. Today's evidence has been favoring differentiation of human ES-cells to functional neuronal cells or b-islet cells and for the successful experimental cell-transplantation in model organisms, which has been quite promising. In this context, environmental and growth factors regulating differentiation of ES-cells are aggressively being studied world over to address neural, cardiac and metabolic disorders like myocardial infraction, spinal cord injury and leg ischaemia.
Embryonic and adult-derived stem cells are today employed for cardiac repair.
A number of stem cell types, including embryonic stem (ES) cells, cardiac stem cells that naturally reside within the heart, myoblasts (muscle stem cells), adult bone marrow-derived cells including mesenchymal cells (bone marrow-derived cells that give rise to tissues such as muscle, bone, tendons, ligaments, and adipose tissue), endothelial progenitor cells (cells that give rise to the endothelium, the interior lining of blood vessels), and umbilical cord blood cells, have been investigated as possible sources for regenerating damaged heart tissue.
Stem cells are likely to contribute to human health and not to immortality as fantasised by the general public. They bridge the gap of isolating therapeutic agents ,which may lead to prolonged life with less suffering and higher quality. Stem cells are the key to replacing cells lost in many devastating diseases such as cancer, cardiovascular , hepato renal and metabolic syndromes like diabetes. For many of these life-shortening diseases there are no effective treatments as yet and the goal is to find a way to replace those natural processes that have been lost. Devastating diseases leading to prolonged hospitalisation and confinement in bed due to neurological problems such as spinal cord injury and multiple sclerosis etc. Highly specialized cells are required for a physiological function such as Pancreatic islets tofacilitate the treatment of chronic diseases such as diabetes. Current challenges include the control of the differentiation process of stem cells and of their development and proliferation once they have been implanted into patients.
In order to safely use stem cells or their differentiated progeny , methods of purification and methods of cell-death control will need to be developed.
Another vital aspect of stem-cell based therapies is to prevent the rejection by the immune system. There is a long way to go before basic research is appllied with stem cell therapy to patients. However, mankind will surely benefit enormously by conducting research in this important area.