Context: In an interim order, the Delhi High Court allowed two children suffering from autism spectrum disorder (ASD) to undergo stem cell therapy for treatment of their condition.
- Earlier, in December 2022, the Ethics & Medical Registration Board said that the use, promotion and advertisement of stem cell therapy shall amount to professional misconduct.
- Experts from AIIMS have maintained that stem cell therapy is allowed as a mode of treatment only for blood cancer and its use for treating autism spectrum disorder is currently at an experimental stage. More research is required about the use of the therapy for ASD before it is prescribed as a treatment.
Stem Cells and Stem Cell Therapy:
- Stem cells are unique cells with the potential to develop into specialised cell types in the body. They can self-renew which makes them valuable for therapeutic applications.
- Stem cell therapy or treatment utilises stem cells to promote the repair, regeneration, or replacement of damaged or diseased tissues within the body.
Uses of Stem Cell Therapy:
- Regenerative Medicine: The technology can replace or regenerate damaged or diseased tissues and organs. This could revolutionise treatments for conditions like spinal cord injuries, heart diseases, Parkinson’s, and diabetes.
- Cell-Based Therapies: Stem cells can be used to create specialised cells for transplantation. E.g., Hematopoietic stem cells are used in bone marrow transplants to treat blood-related disorders and cancers.
- Personalised Medicine: Potential to create patient-specific therapies by using patient’s own cells to generate replacement tissues, reducing the risk of immune rejection and the need for organ donation.
- Drug Testing/Disease Modeling: Used to create disease-specific cell models, enabling researchers to better understand diseases and develop new drugs. This reduces the need for animal testing and enhances the accuracy of drug testing.
Status of Stem Cell treatment in India:
- Stem Cell Treatment is still under research mode in India and the Government is supporting various basic pre-clinical and clinical research.
- Indian Council of Medical Research has released the National Guidelines for Stem Cell Research (NGSCR) 2017, through which the government has supported the ethical and scientific conduct of stem cell research.
- As per the NGSCR 2017, only bone marrow/hematopoietic stem cell transplantation for blood disorders (including blood cancers and thalassemia) is permitted use of stem cells. This is known as bone marrow transplant (BMT) or hematopoietic stem cell transplant (HSCT).
- At present, stem cell therapy other than BMT/HSCT for conditions listed in the NGSCR 2017 is neither available nor permissible. For other diseases, studies are being conducted to find if stem cells can help cure these diseases.
- Ethical Considerations: The use of embryonic stem cells raises ethical concerns, as their extraction from embryos results in destruction of the embryo.
- Tumour Formation: In certain cases, stem cells can form tumours if they differentiate in an uncontrolled manner.
- Immune Rejection: Even if the patient’s own cells are used, there is some possibility of immune rejection.
- Cost and Accessibility: Stem cell therapies can be expensive, limiting access for many patients.
- Regulation: Through India has “National Guidelines for Stem Cell Research 2017”, however, as the field of stem cell research and therapy is rapidly evolving, challenges may arise regarding its oversight and regulation.
- Developing clear and appropriate regulations for stem cell research and product development.
- Informed Consent for trials and potential risks arising out of it.
- Developing affordable and accessible therapies.
- International collaboration for sharing best practices and advancement of technology for responsible development.
Stem cell technology has the potential to revolutionise medicine and scientific understanding, however, its challenges must be addressed responsibly through rigorous research, ethical considerations, and effective regulatory oversight.