The Delhi High Court Thursday (August 31) permitted two children with autism spectrum disorder (ASD) to undergo stem cell therapy for treatment of their condition.
The order came in a petition moved by family members of the two children, challenging a December 6, 2022 recommendation of the Ethics and Medical Registration Board (EMRB) of the National Medical Commission (NMC) against the use of stem cell treatment for ASD.
“No fruitful purpose will be served by stopping the treatment which is going on at present and therefore, the petitioners are permitted to continue the treatment,” a division bench of Chief Justice Satish Chandra Sharma and Justice Sanjeev Narula ruled.
After the EMRB recommendation, which said that “the use, promotion and advertisement of stem cell treatment shall amount to professional misconduct”, the children’s doctors stopped the stem cell treatment, prompting the parents to approach the court.
Here, we explain stem cell treatment, why some doctors have used it to treat autism, and why the EMRB has recommended against it.
What are stem cells?
Simply put, stem cells are cells from which all other cells, with their respective specialised functions, are generated. The human body, under certain conditions, “divides” stem cells to either create new stem cells or cells with specific functions, such as blood cells, brain cells, bone cells, muscle cells, etc.
There are two main categories of stem cells: pluripotent stem cells, or cells with the ability to differentiate into all of the cells of the adult body, and adult stem cells, which are tissue or organ-specific and regenerate to form cells only of that particular organ.
Pluripotent stem cells are naturally found only in embryos. However, in 2006, researchers identified conditions that would allow some mature human adult cells to be reprogrammed into an embryonic stem cell-like state. Those reprogrammed stem cells are called induced pluripotent stem cells.
How are stem cells used in medicine?
The regenerative properties of stem cells make them extremely valuable in medicine. This is why stem cell treatments are also termed as regenerative medicine.
For over 90 years now, hematopoietic stem cell transplantation has been used to treat people with conditions such as leukaemia and lymphoma. After chemotherapy or radiation therapy wrecks the patient’s healthy cells (along with the cancerous ones), a donor’s healthy bone marrow reintroduces functional stem cells to replicate inside of a patient and to produce additional normal blood cells.
There are typically a very small number of adult stem cells in each tissue, and once removed from the body, their capacity to divide is limited. This is the fundamental limitation of stem cell therapies at the moment. That is why, scientists have been focussed on manipulating adult stem cells to exhibit characteristics of pluripotent stem cells.
What is autism spectrum disorder and how is it treated?
Autism spectrum disorder is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave.
According to the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM-5), people with ASD often have difficulty with communication and interaction with other people, restricted interests and repetitive behaviours, and symptoms that affect their ability to function in school, work, and other areas of life.
Currently, there is no cure for ASD – treatments and therapies are geared towards managing symptoms and helping someone with ASD lead a happy and functional life. Conventional therapies include social skills training, early intensive behaviour therapy, applied behaviour analysis, speech therapy, and occupational therapy. Psychotropic drugs and transcranial magnetic stimulation are also commonly used.
Can stem cell treatment be used for ASD?
According to some experts, ASD has potential to be a good candidate for stem cell therapy because evidence exists that some types of stem cells, given intravenously, can improve the overall regulation of the immune system and the neural connectivity in the brain.
However, stem cell therapy is not typically used for treating ASD yet, and initial clinical trials have shown mixed results. Currently, the treatment is very much in an experimental stage and there is simply not enough data to make definitive claims.
This is why EMRB made recommendations against its use. It is not that there is absolutely no possibility of the therapy helping, there is just not sufficient evidence, especially given the general risks associated with the treatment which includes adverse reactions and painful, potentially debilitating side effects. There is also limited understanding of its long term effects and as pointed out by doctors representing the EMRB, there is no established protocol for its use to treat autism.
EMRB’s recommendation came on the back of what it called “predatory marketing” of stem cell therapy “which gave false hope” to parents and caregivers regarding the possibility of “curing” ASD.
Crucially, the High Court does not opine on the general validity of using stem cell therapies for ASD, but in these two cases, allows ongoing treatment to continue. The HC bench said that the NMC is permitted to take a final view on the recommendation as per provisions of the NMC Act.
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