NMC slams Stem Cell Therapy for treating Autism Spectrum Disorder, declares it as Professional Misconduct

New Delhi: Submitting its report regarding the treatment method for Autism Spectrum Disorder (ASD), a committee of the National Medical Commission (NMC) has dismissed Stem Cell therapy listing the use of Stem Cell in ASD, its promotion and advertisement as professional misconduct.

The committee in its report opined, "...more well-designed and methodologically sound research needs to explore the safety and utility of SCT in ASD."

Ethics and Medical Registration Board (EMRB) of the Apex medical commission had constituted the panel of experts to examine the issues related to prescription, recommendation or administration of stem cell treatment for ASD.

Accordingly, the NMC committee has recently submitted its report and discussed in detail about the current understanding of ASD, stem cells in health and SCT research in ASD, well-established clinical uses of SCT and recommendation of SCT for treating ASD.

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Referring to ASD, the committee stated in its report that "Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder. The complexity of ASD comes from range of severity, presence of variety of comorbidities, and aetiological heterogeneity. ASD causes life-long disability; however, they improve with developmental, behavioral, educational, and other interventions, especially when started early in life because of developmental plasticity."

On the other hand, stem cells are special human cells that are able to develop into many different cell types and are capable of self-renewal. They play an important role in repair and regeneration of various tissues and organs in the body. They have been harnessed for research and for therapy. Blood cancers and certain other haematologic disorders are the most well-established and internationally accepted clinical indications for Hematopoietic Stem cell transplantation.

The panel mentioned that SCT has been investigated as a possible treatment option in ASD, based on the unproven hypothesis that this treatment helps in offering neural cell protection by enhancing neural tissue repair and preventing ongoing neuronal damage, thereby reducing the severity of autistic symptoms.

"ln terms of research, there have been numerous case reports, case series, and uncontrolled open label studies. But very few well-designed double-blind randomised controlled studies (RCT'S) have been conducted. ln general, the quality of research in this area has been poor," the panel mentioned in its report.

"The largest and a well-designed double-blind randomised placebo-controlled study of SCT in ASD was by Geraldine Dawson and her co-workers in 2020. 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. ln conclusion, this well-conducted study with a large sample found that SCT was not effective in ASD," it added.

The NMC panel mentioned that two meta-analysis have been published on this topic in the last 1-2 years and both have noted that scientific quality of most studies has been inadequate. Therefore, the panel opined that it is not possible to draw any firm conclusions on the eficacy of SCT in ASD.

"None of the current international guidelines recommend SCT as a treatment for ASD. Similarly, many eminent researchers and leaders the lack of sufficient scientific evidence. They also have noted prevailing unethical practice of offering SCT as a treatment for ASD. Further, they have expressed concern and warned about indiscriminate promotion and predatory marketing of stem cell therapies in ASD leading to creation of false hopes, unrealistic expectations, and exploitation of the affected population and their families," mentioned the panel.

"National and international guidelines, including ICMR guidelines are unform in their conclusion that there is insufficient evidence for SCT in ASD and do not recommend it as a treatment for ASD, and call for more high-quality research. Many experts in the field have noted prevailing unethical practice of offering SCT as a treatment for ASD. Further, they have expressed concern and warned about indiscriminate promotion and predatory marketing of stem cell therapies in ASD leading to creation of false hopes, unrealistic expectations, and exploitation of the affected population and their families," the committee further mentioned in its report.

"In conclusion, there is as yet insufficient and inadequate scientific evidence on efficacy of the SCT in ASD. Therefore, SCT cannot be recommended as it treatment for ASD," the report further stated.

Therefore, clarifying that stem cell therapy is not recommended as a treatment for Autism Spectrum Disorder (ASD) in clinical practice, the panel further clarified, "ln view of the above recommendation, use of Stem cell in ASD, its promotion and advertisement will be considered as professional misconduct."

"Further research needs to be conducted and encouraged in terms of well designed Double-blind RCT's to explore the safety and efficacy of Stem Cell Therapy in ASD. These recommendations will be updated periodically," it added.

To view the official Notice, Click here : https://medicaldialogues.in/pdf_upload/recommendations-on-stem-cell-use-in-asd-193790.pdf

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