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New Indian guidelines on Stem Cell Research stir hot debate

Date (2017-11-09)

Even as GlaxoSmithKline and Plasticell have partnered to manufacture hematopoietic cells from induced pluripotent stem cells, based on molecular combinations to be provided by GSK, the Indian government has updated national guidelines on stem cell research to curb what officials term is the 'indiscriminate use' of stem cells for medical disorders, reports The Pharma Letter’s India correspondent.

The revized guidelines have set the ‘cat among the pigeons’ spurring a debate in India on the regulation of stem cell banking, with industry experts terming the move as detrimental and claiming it would impede research, given that human stem cells may soon hold the key to tackling diabetes and even aid dystrophy.

The guidelines have been revized after about a decade. In order to curb the misuse of stem cell treatments, the Indian Council for Medical Research (ICMR) and the Department of Biotechnology helped with the update, restricting the use of stem cell therapy and cautioning that all other medical applications of stem cells should be viewed as clinical research.

The guidelines state the commercial use of stem cells as elements of therapy is prohibited. Even hematopoietic stem cell transplantations (HSCT) are only allowed for certain types of leukemia, lymphomas (cancer of the immune system and white blood cells), plasma cell disorders, tumors and non-malignant diseases.

This differs for adults and children, with children being allowed HSCT for fewer types of cancers and more types of non-malignant diseases, according to the new guidelines.

Usage difference

The guidelines reiterate that stem cell use in patients is investigational at present, with the exception of hematopoietic stem cell reconstitution "for approved indications." Hematopoietic stem cells are stem cells that are usually derived from the bone marrow, peripheral blood or umbilical cord blood.

For adults, stem cells can be used for therapeutic purposes in different cases of leukemia  and lymphomas (cancer of the lymphatic system), solid tumours such as germ cell, and non-cancerous diseases of the blood such as severe aplastic anaemia, sickle cell disease, among others.

In children, the therapy is permitted in different types of blood cancers, solid tumours of brain, bones, etc, and non-cancerous diseases such as thalassemia major, juvenile rheumatoid arthritis, and osteoporosis, among others.

Earlier, the Indian government had placed a temporary ban on the commercial banking of stem cells derived from biological materials such as cord tissue, placenta and the like, in the absence of scientific evidence about its benefits.

Huge debate

The temporary ban has not gone down well with the industry. The ICMR functions under the ministry of health.

Mayur Abhaya, chief executive of LifeCell, a prominent umbilical cord stem cell bank, has questioned the guideline, saying that the observation will have consequences in the longer term. He adds that the preservation of biological material is imperative given the massive research taking place across the globe.

Recently, Stempeutics Research, a group company of Manipal Education and Medical Group and a joint venture with the Cipla Group, received approval to commercialize its product Stempeucel, a cultured adult allogeneic mesenchymal stem cells derived from bone marrow for treatment. The product was approved for treating critical limb ischemia due to Buerger’s disease.

The ban appears inconsistent to this approval issued by the DCGI, said Mr Abhaya, who is also the president of the Association of Stem Cell Banks of India.

He added that ICMR guidelines disregard global practices. "Preservation of cord tissue and other source of stem cells have been prevalent across the globe. Advanced economies like the US and Europe have been encouraging support towards licensing and registration of such banking practices," he said. In India, however, the guidelines can curtail the future potential of stem cell treatments, he added.

Stating that with many ongoing scientific research and clinical trials substantiating significant progress of cord tissue stem cells, "it is not possible to ignore the unending possibilities that the Mesenchymal Stem Cells (MSC) can provide for individuals," he said.

Mr Abhaya added in targeting the banking of the MSCs, "the ICMR has lost perspective of the objective sought to be achieved. The objective is clearly to prevent misuse in the form of treatments using the MSCs without proven clinical evidence. By targeting 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 developed as a proven therapy."

Stem cells have changed the landscape of medicine with a new approach of regenerative medicine. It has a promising future for patients suffering from medical conditions that currently lack successful standard treatments, said Vipul Jain, CEO, Advancells, a company working in the field of regenerative medicine.

The company recently announced successful reversal of multiple sclerosis using adult stem cells and regenerative medicine in a pilot patient of a planned 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.