Autism Treatment and Stem Cell Therapy

Context

In a significant decision, the Supreme Court clarified that stem cell therapy for the treatment of autism spectrum disorder (ASD) cannot be offered as a routine medical service. According to the Court, it should be limited to duly approved and monitored clinical trials or research settings.

Key Points

Concerns over Lack of Scientific Evidence

• Scientific information regarding the use of stem cells in the treatment of ASD is still incomplete and uncertain. In the absence of solid evidence regarding its effectiveness and potential side effects, providing such therapy by doctors would be considered a violation of the "standard of reasonable care" towards patients.
• The Court observed that there is no established scientific evidence proving the safety and efficacy of stem cell-based treatments for autism spectrum disorder. Therefore, doctors lack the basis to provide accurate and complete information to patients.
• The petitions argued that the government had erred in not permitting stem cell therapy, thereby violating the new Drugs and Clinical Trials Rules, 2019, framed under the Drugs and Cosmetics Act, 1940, and the National Stem Cell Research Guidelines, 2017, issued by the Indian Council of Medical Research (ICMR).

About Stem Cell Therapy

• Stem cell therapy or stem cell treatment is a therapeutic method that uses stem cells to treat or manage various medical conditions.
• Stem cells are undifferentiated cells that have the potential to develop into various types of cells in the body, such as muscle, bone, or nerve cells.
• Stem cell therapy aims to harness the regenerative and repair capabilities of stem cells to treat or manage diseases and injuries for which there are currently limited treatment options.
• This innovative therapeutic approach takes advantage of the unique properties of stem cells, including their ability to differentiate into various cell types and their ability to regulate the immune system and reduce inflammation.

Goals of Stem Cell-Based Therapies

• The primary goal of stem cell therapy is to treat or manage a variety of medical conditions by harnessing the regenerative and repair capabilities of stem cells. Specifically, this treatment aims to:
  • Promote tissue regeneration: Stem cells can differentiate into various cell types, aiding in the repair and regeneration of damaged tissues, such as muscle, bone, or nerve cells.
  • Regulate the immune system: Stem cells possess immune-modulating properties that may help manage autoimmune disorders by reducing abnormal immune responses.
  • Reduce inflammation: Stem cells can secrete anti-inflammatory factors that help reduce systemic and local inflammation, relieving symptoms of chronic inflammatory conditions.
  • Improve quality of life: By addressing the root causes of degenerative diseases and injuries, stem cell therapy aims to improve overall quality of life for patients, providing relief from symptoms, and potentially slowing disease progression.

Challenges

• Stem cell therapy has immense potential for treating a variety of diseases, but it also faces several challenges, including:
  • Risk of tumor formation
  • Rejection by the immune system
  • Requirement of large numbers of cells
• Advances in research and clinical use will be crucial to overcome these challenges and realize the full potential of stem cell therapy.