The National Medical Commission (NMC) has warned against the use of stem cell therapy for treating autism due to inadequate scientific evidence on its efficacy and said its promotion and advertisement will be considered as "professional misconduct".
The Ethics and Medical Registration Board (EMRB) of the NMC said more research needs to be conducted and encouraged in terms of well-designed double-blind randomised controlled trials to explore the safety and efficacy of stem cell therapy (SCT) in Autism Spectrum Disorder (ASD) .
The recommendations by a committee of experts constituted by the EMRB of the NMC to examine the issues related to prescription, recommendation of administration of SCT for ASD have come following a court order as their use has become prevalent despite there being not much of scientific evidence on its efficacy, Yogendra Malik, EMRB member told PTI.
National and international guidelines, including those by the ICMR, are uniform in their conclusion that there is insufficient evidence for SCT in ASD. The guidelines do not recommend it as a treatment for ASD and call for more high-quality research, the committee said in its report.
Several experts in the field have noted prevailing unethical practice of offering SCT as a treatment for ASD. They have also expressed concern and warned about its indiscriminate promotion, it said.
Five randomised controlled trials/controlled clinical trials of SCT in ASD have so far been conducted. The largest and a well-designed double-blind randomised placebo controlled study was by Geraldine Dawson in 2020, the committee said.
ln this study of 180 children with ASD, SCT was given to 119 children with ASD, with 61 controls. At the end of 6 months, there was no difference between cases and controls on any of the primary outcome measures, it said.
Another controlled trial by Chez from the US also did not find any difference between SCT and placebo. The other three trials -- one from Iran and two from China -- did find some benefit, the committee said in its report.
However, these studies were found to be inadequate in terms of their methodological rigour and therefore the reliability of their results is questionable.
Thus, it can be safely concluded that as of now, there is no clear evidence that SCT is efficacious in ASD, it said.
Predatory marketing of SCT in ASD leading to creation of false hopes, unrealistic expectations, and exploitation of the affected population and their families, the committee said.
"These recommendations are in response to the court case where the court wanted us to constitute a committee and give recommendation whether stem cell procedure should be used in autism or not because its use has become very frequent despite the fact that we don't have so much of scientific evidence for use of stem of therapy in autism treatment," Malik said.
"That's why the NMC has come up with these recommendations," he said.
There is no treatment that can "cure" ASD. Parent and caregiver education and counselling is the first step, so that it helps them to understand, accept and cope with their child's problem and also learn how to be part of home-based parent mediated intervention, the committee said in its report.
A number of management approaches have been found to be beneficial in improving the core manifestations of ASD, improving their skills and competencies, and reducing comorbid problems, it said.
These include behavioural interventions such as Applied Behavioural analysis (ABA), Naturalistic developmental behavioral interventions such as early start denver model, speech /language therapy, occupational therapy, educational approaches, and pharmacological management of comorbid problems such as epilepsy, sleep disorders, and behavioural/psychiatric problems.
The physical investigations varies from case to case and may include genetic, metabolic, electrophysiological and neuro-imaging studies. Genetic counselling needs to be carried out whenever needed. To conclude, ASD is multifactorial in origin with no established cure, the committee said in its report.
Existing evidence supports the role of behavioural, developmental, and educational interventions as the primary therapeutic modalities for children with ASD, the report said.
Pharmacotherapy may help treat medical and psychiatric comorbidities to some extent, enabling them to function better and benefit more from different therapies, it said.
