The Supreme Court of India has held that administering stem cell therapy for the treatment of Autism Spectrum Disorder (ASD) is unethical and amounts to medical malpractice if it is outside an approved and monitored clinical trial. A bench of Justices JB Pardiwala and R Mahadevan ruled that stem cell therapy is not recognised as a sound and relevant medical practice due to the lack of scientific support and empirical evidence on its efficacy.“Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice,” the Supreme Court ruled.The stem cell therapy is permissible only for approved and monitored clinical trials with the intent to advance science, the bench added.&nbsp;&nbsp;Also Read: <a href="https://www.wionews.com/world/trump-slams-powell-says-unnecessary-high-interest-rates-hurting-economy-national-security-1769702026051">Trump slams Powell, says unnecessary high interest rates hurting economy, national security</a><h2>‘Mere classification of stem cells as drugs not enough’</h2>&nbsp;The court also made it clear that the mere classification of stem cells as “drugs” under the Drugs and Cosmetics Act, 1940, does not make their therapeutic use for autism permissible as a clinical service.“Although the stem cells administered for therapeutic use in ASD are characterised as drugs under the Drugs Act, 1940, the same by itself is not determinative of the fact that it is permissible to be administered as a clinical service,” the bench said.If doctors offer such treatment as a routine clinical service, they fail to meet the reasonable standard of care owed to patients.&nbsp;Also Read: <a href="https://www.wionews.com/india-news/economic-survey-flags-rising-digital-addiction-among-kids-youth-in-india-will-govt-put-curbs-1769688736105">Economic Survey flags rising digital addiction among kids, youth in India. Will govt put curbs?</a><h2>‘Every medical practitioner owes a duty to…’</h2>&nbsp;The bench observed that every medical practitioner owes a duty to exercise a reasonable degree of care, skill and knowledge expected of a prudent practitioner in the field.&nbsp;It further said that this standard is breached when doctors administer interventions that lack credible scientific backing or are expressly discouraged by authoritative medical bodies.“A medical practitioner cannot be said to meet the standard of reasonable care if he administers an intervention that lacks credible scientific evidence of safety and efficacy or where authoritative medical bodies unequivocally state that such a form of treatment is not recommended,” the judgment said.&nbsp;&nbsp;Also Read: <a href="https://www.wionews.com/india-news/menstrual-hygiene-is-fundamental-right-supreme-court-orders-free-pads-for-school-girls-1769770333164">Menstrual hygiene is fundamental right: Supreme Court orders free pads for school girls</a><h2>‘Consent invalid if it is not based on…’</h2>&nbsp;After examining the recommendations of the Ethics and Medical Registration Board of the National Medical Commission dated December 6, 2022, read with the Ethical Guidelines for Biomedical and Social Science Research, the National Guidelines for Stem Cell Research, 2017, and the National Ethical Guidelines formulated by the Indian Council of Medical Research, the court noted that these documents clearly state that stem cell therapy for autism is not recognised as a sound or relevant medical practice.“It is categorically mentioned therein that any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine and not offering it as therapy,” the bench said.&nbsp;The court also held that consent is invalid if it is not based on adequate and credible scientific information.The court noted that offering a choice between no treatment and an unproven therapy does not amount to valid consent, especially when families are emotionally vulnerable.

The court said that consent is invalid if it is not based on adequate and credible scientific information, and it further noted that offering a choice between no treatment and an unproven therapy does not amount to valid consent, especially when families are emotionally vulnerable.

The Supreme Court of India has held that administering stem cell therapy for the treatment of Autism Spectrum Disorder (ASD) is unethical and amounts to medical malpractice if it is outside an approved and monitored clinical trial. A bench of Justices JB Pardiwala and R Mahadevan ruled that stem cell therapy is not recognised as a sound and relevant medical practice due to the lack of scientific support and empirical evidence on its efficacy. “Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice,” the Supreme Court ruled. The stem cell therapy is permissible only for approved and monitored clinical trials with the intent to advance science, the bench added. Also Read: Trump slams Powell, says unnecessary high interest rates hurting economy, national security ‘Mere classification of stem cells as drugs not enough’ The court also made it clear that the mere classification of stem cells as “drugs” under the Drugs and Cosmetics Act, 1940, does not make their therapeutic use for autism permissible as a clinical service. “Although the stem cells administered for therapeutic use in ASD are characterised as drugs under the Drugs Act, 1940, the same by itself is not determinative of the fact that it is permissible to be administered as a clinical service,” the bench said. If doctors offer such treatment as a routine clinical service, they fail to meet the reasonable standard of care owed to patients. Also Read: Economic Survey flags rising digital addiction among kids, youth in India. Will govt put curbs? ‘Every medical practitioner owes a duty to…’ The bench observed that every medical practitioner owes a duty to exercise a reasonable degree of care, skill and knowledge expected of a prudent practitioner in the field. It further said that this standard is breached when doctors administer interventions that lack credible scientific backing or are expressly discouraged by authoritative medical bodies. “A medical practitioner cannot be said to meet the standard of reasonable care if he administers an intervention that lacks credible scientific evidence of safety and efficacy or where authoritative medical bodies unequivocally state that such a form of treatment is not recommended,” the judgment said. Also Read: Menstrual hygiene is fundamental right: Supreme Court orders free pads for school girls ‘Consent invalid if it is not based on…’ After examining the recommendations of the Ethics and Medical Registration Board of the National Medical Commission dated December 6, 2022, read with the Ethical Guidelines for Biomedical and Social Science Research, the National Guidelines for Stem Cell Research, 2017, and the National Ethical Guidelines formulated by the Indian Council of Medical Research, the court noted that these documents clearly state that stem cell therapy for autism is not recognised as a sound or relevant medical practice. “It is categorically mentioned therein that any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine and not offering it as therapy,” the bench said. The court also held that consent is invalid if it is not based on adequate and credible scientific information. The court noted that offering a choice between no treatment and an unproven therapy does not amount to valid consent, especially when families are emotionally vulnerable.

The court said that consent is invalid if it is not based on adequate and credible scientific information, and it further noted that offering a choice between no treatment and an unproven therapy does not amount to valid consent, especially when families are emotionally vulnerable.

‘Stem cell therapy for autism is unethical, medical malpractice,’ says Supreme Court

A clinical trial has revealed that stem cells taken from body fat can help restore movement in patients affected by paralysis and can improve sensation. A small trial at Mayo Clinic, a nonprofit American academic medical centre, has shed light on the potential benefit of stem cells and regenerative medicine. Thanks to stem cell therapy, a patient who was paralysed from the neck down following an accident was able to walk again.

The first author of the study, Mohamad Bydon, MD, a Mayo Clinic neurosurgeon, said in a press release, "This study documents the safety and potential benefit of stem cells and regenerative medicine." "In spinal cord injury, even a mild improvement can make a significant difference in that patient's quality of life," he said.

<h2>How was the study conducted?</h2>

The phase 1 study involved 10 patients who got their stem cells removed from their abdomen or thigh. Following this, millions of new mesenchymal stem cells (MSCs) were grown in the lab over the next several weeks. These cells were then injected into each patient’s lumbar spine.

Also read:&nbsp;<a data-ved="2ahUKEwj5yv2Vx8GFAxXQ8DgGHZzSAKIQxfQBKAB6BAgQEAE" href="https://www.wionews.com/science/shocking-revelation-no-gold-and-platinum-formed-by-brightest-supernova-710617" jsname="YKoRaf" ping="/url?sa=t&amp;source=web&amp;rct=j&amp;opi=89978449&amp;url=https://www.wionews.com/science/shocking-revelation-no-gold-and-platinum-formed-by-brightest-supernova-710617&amp;ved=2ahUKEwj5yv2Vx8GFAxXQ8DgGHZzSAKIQxfQBKAB6BAgQEAE">Shocking revelation! No Gold and Platinum formed by brightest supernova</a>

It was observed that these cells migrated to the injured part of the spine and helped in recovery. The patients were assessed for the next two to three years for their response to the injection.

<h2>Results</h2>

The results, published in the journal Nature Communications, showed that seven of the 10 patients showed improvements in sensation and movement.

Patients exhibited stronger muscles and better reactions to light touches.

Also read:&nbsp;<a data-ved="2ahUKEwj5yv2Vx8GFAxXQ8DgGHZzSAKIQxfQBKAB6BAgKEAE" href="https://www.wionews.com/science/scientists-discover-two-great-techniques-to-overcome-past-negative-events-710861" jsname="YKoRaf" ping="/url?sa=t&amp;source=web&amp;rct=j&amp;opi=89978449&amp;url=https://www.wionews.com/science/scientists-discover-two-great-techniques-to-overcome-past-negative-events-710861&amp;ved=2ahUKEwj5yv2Vx8GFAxXQ8DgGHZzSAKIQxfQBKAB6BAgKEAE">Scientists discover two great techniques to overcome past negative events</a>

The most promising results were observed in a patient named Chris Barr. The California man got paralysed in 2017 after an accident. After 18 months following the injection of stem cells, Barr was able to walk again.

"I never dreamed I would have a recovery like this," Barr was quoted as saying by ABC News. "I can feed myself. I can walk around. I can do day-to-day independent activities," he added.

Scientists said the therapy showed no adverse effects.&nbsp;

(With inputs from agencies)

A clinical trial has revealed that stem cells taken from body fat can help restore movement in patients affected by paralysis and can improve sensation. A small trial at Mayo Clinic, a nonprofit American academic medical centre, has shed light on the potential benefit of stem cells and regenerative medicine.

A clinical trial has revealed that stem cells taken from body fat can help restore movement in patients affected by paralysis and can improve sensation. A small trial at Mayo Clinic, a nonprofit American academic medical centre, has shed light on the potential benefit of stem cells and regenerative medicine. Thanks to stem cell therapy, a patient who was paralysed from the neck down following an accident was able to walk again. The first author of the study, Mohamad Bydon, MD, a Mayo Clinic neurosurgeon, said in a press release, "This study documents the safety and potential benefit of stem cells and regenerative medicine." "In spinal cord injury, even a mild improvement can make a significant difference in that patient's quality of life," he said. How was the study conducted? The phase 1 study involved 10 patients who got their stem cells removed from their abdomen or thigh. Following this, millions of new mesenchymal stem cells (MSCs) were grown in the lab over the next several weeks. These cells were then injected into each patient’s lumbar spine. Also read: Shocking revelation! No Gold and Platinum formed by brightest supernova It was observed that these cells migrated to the injured part of the spine and helped in recovery. The patients were assessed for the next two to three years for their response to the injection. Results The results, published in the journal Nature Communications, showed that seven of the 10 patients showed improvements in sensation and movement. Patients exhibited stronger muscles and better reactions to light touches. Also read: Scientists discover two great techniques to overcome past negative events The most promising results were observed in a patient named Chris Barr. The California man got paralysed in 2017 after an accident. After 18 months following the injection of stem cells, Barr was able to walk again. "I never dreamed I would have a recovery like this," Barr was quoted as saying by ABC News. "I can feed myself. I can walk around. I can do day-to-day independent activities," he added. Scientists said the therapy showed no adverse effects. (With inputs from agencies)

Paralysed patient walks after 7 years as stem cell therapy shows promising results

A recent study shows stem cells derived from patients' own fat are safe and may improve sensation and movement after traumatic spinal cord injuries. Watch in for more details!

Experimental Stem Cell therapy for severe injuries

Experimental therapy could offer life-changing improvements to patients suffering from devastating injuries. Watch to know more.

Experimental stem cell therapy shows promise for paralysed individuals

Heart surgeon Massimo Caputo from the Briston Heart Institute used what is called stem cell scaffolding to correct a baby's heart defect. With this advanced technology, he hopes that children who are born with congenital cardiac disease won't need as many operations. Watch this to know more.

Doctors may have saved a baby's heart using umbilical stem cells