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Even as GlaxoSmithKline and Plasticell have amalgamated to manufacture hematopoietic cells from induced pluripotent stem cells, centered on molecular combinations to be provided by GSK, the Indian government has reorganized national guidelines on stem cell research to limit what officials term is the un-selective use of stem cells for medical disorders, reports The Pharma Letter’s India correspondent.

The revised guidelines have “set the cat amid the pigeons”urging a debate in India on the regulation of stem cell banking, with industry specialists terming the move as damaging and claiming it would hamper research, given that human stem cells might soon hold the key to tackling diabetes and even aid dystrophy. The strategies have been revised after about a decade. So as tocontrol the misuse of stem cell treatments, the Indian Council for Medical Research (ICMR) and the Department of Biotechnology assisted with the update, restricting the use of stem cell therapy and admonishing that all other medical applications of stem cells should be observed as clinical research.

The guidelines state the commercial use of stem cells as elements of therapy is prohibited. Even hematopoietic stem cell transplantation (HSCT) are only permitted for certain kinds of leukemia, lymphomas (cancer of the immune system and white blood cells), plasma cell disorders, tumors and non-malignant ailments. This varies for adults and children, with kids being permitted HSCT for fewer categories of cancers and more types of non-malignant diseases, as per the new guidelines.

 Usage difference

The guidelines repeat that stem cell use in patients is investigational right now, with the exclusion of hematopoietic stem cell reconstitution for approved indications. Hematopoietic stem cells are stem cells that are typically derived from the bone marrow, peripheral blood or umbilical cord blood. For grown-ups, stem cells can be used for therapeutic purposes in diverse cases of leukemia and lymphomas (cancer of the lymphatic system), solid cancers such as germ cell and non-cancerous diseases of the blood such as severe aplastic anaemia, sickle cell disease, amid others. In kids, the therapy is permitted in diverse types of blood cancers, solid tumors of brain, bones, etc., and non-cancerous ailments such as thalassemia major, juvenile rheumatoid arthritis and osteoporosis. Previously, the Indian government had employed a temporary ban on the commercial banking of stem cells derived from biological materials such as cord tissue, placenta and the like, in the nonexistence of scientific proof about its benefits.

Huge debate

The provisional ban has not gone down well with the industry. The ICMR functions under the ministry of health. MayurAbhaya, chief executive of LifeCell, a conspicuous umbilical cord stem cell bank, has interrogated the guideline, saying that the observation will have penalties in the longer term. He adds that the conservation of biological material is vital given the massive research taking place across the globe.Recently, Stempeutics Research, a group enterprise of Manipal Education and Medical Group and a joint project with the Cipla Group, got approval to commercialize its product Stempeucel, cultured adult allogeneic mesenchymal stem cells derived from bone marrow for treatment. The product was approved for treating critical limb ischemia attributable toBuerger’s disease. The ban seems inconsistent to this approval dispensed by the DCGI, said MrAbhaya, who is also the president of the Association of Stem Cell Banks of India. He added that ICMR guidelines disrespect global practices. “Preservation of cord tissue and other source of stem cells have been rampant across the globe. Advanced economies like the US and Europe have been inspiring support towards licensing and registration of such banking practices,” he said. In India, however, the strategies can limit the future potential of stem cell treatments, he added.

Affirming that with many enduring scientific research and clinical trials validating significant progress of cord tissue stem cells, “it is not possible to overlook the endless possibilities that the Mesenchymal Stem Cells (MSC) can offer for individuals,” he said.MrAbhaya added in targeting the banking of the MSCs, “The ICMR has lost standpoint of the objective sought to be accomplished. The objective is evidently to prevent misuse in the form of treatments using the MSCs without verified clinical evidence. By aiming the banking of the MSCs, the ICMR is preventing access to the public of the benefits at a future point of time when these could well be industrialized as a proven therapy.”

Stem cells have changed the scenery of medicine with a new methodology of regenerative medicine. It has a promising future for patients suffering from medical disorders that presently lack successful standard treatments, said CEO of Stem Cell Care India, a firm working in the field of regenerative medicine. The firm recently announced successful reverse of multiple sclerosis using adult stem cells and regenerative medicine in a pilot patient of a prearranged clinical trial.

Helping hand

Despite the temporary ban, India has been showing the way in stem cell research, and has had many developments. At the National Center for Biological Sciences in Bengaluru, an experiment using fruit flies, and a new group of stem cells that are involved in the repair of injured tissue, is helping researchers understand muscle disorders in humans.Recently, India and Japan joined hands for stem cell research. Though India’s DBT and Japan’s National Institute of Advanced Industrial Science and Technology have been collaborating in these areas, they have renewed the agreement for five more years. The aim of the program is to develop infrastructure and expertise for India to be a competitive force in regenerative medicine and induced pluripotent stem cell biology. The focus of the collaboration is on developing treatments for sickle-cell anaemia, Beta thalassemia and brain disorders, and creating a haplobank relevant to Indian populations. There are Indian companies that have approvals in place for stem cell-based products, for treatment in the areas of type 2 diabetes, Graft versus Host disease, ILD, and many are conducting research to tackle MS, Parkinson’ s, Alzheimer’s and spinal cord injury, among others.Sources also pointed out that a public sector stem cell bank is soon to come up at Lucknow’s King George’s Medical University. A project of the university’s transfusion medicine department, the stem cell bank would roll out stem cell therapy to patients of thalassemia and sickle cell anemia.