In order to curb the misuse of stem cell treatments, the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT) released updated national guidelines on Wednesday that restrict the use of stem cell therapy.
For adults, stem cells can be used for therapeutic purposes in different cases of leukemia (cancer of the blood) 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 also 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 osteopetrosis, among others.
At the moment, certain medical practitioners offer stem cell therapy for conditions even outside their speciality and for conditions where there has been no proven cure through this treatment.
“The 2017 guidelines reiterate that any stem cell use in patients, other than that ... for approved indications, is investigational at present... every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice,” says the report.
An expert, on condition of anonymity, said, “Even clinical trials in stem cell treatments should only be done by domain experts. However, these days you would find stem cell clinics almost everywhere. It is an expensive treatment modality and you can’t fool people.”
{{/usCountry}}An expert, on condition of anonymity, said, “Even clinical trials in stem cell treatments should only be done by domain experts. However, these days you would find stem cell clinics almost everywhere. It is an expensive treatment modality and you can’t fool people.”
{{/usCountry}}The guidelines elaborately mention categories where stem cell use “permissible, restrictive or prohibited”.
The use of stem cells has been strictly prohibited in human germ line gene therapy, wherein changes are made to the DNA that will be passed on to the next generation, and human cloning; use of gene modified human embryos; breeding of animals in which any type of human stem cells have been introduced at any stage of development, etc.
“India has a large unmet medical need, which requires facilitation of safe and regulated translational and clinical stem cell research,” says the report.
Dr Soumya Swaminathan, director general, ICMR, said, “These are the updated guidelines keeping in mind the advances that have happened in the field. It is a fast-paced area and needs constant upgradation.”
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