Indian surgeon vows to continue stem cell research on brain dead patientsBMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i3930 (Published 14 July 2016) Cite this as: BMJ 2016;354:i3930
An Indian surgeon has vowed to continue with a clinical trial he claims will “reverse” brain death, despite strong criticism by the Indian Council of Medical Research (ICMR).
The ICMR has warned Himanshu Bansal, a spine surgeon based in the northern Indian town of Rudrapur, that his proposal to look for evidence of reversal of brain death would violate guidelines for human research.
India’s National Apex Committee for Stem Cell Research and Therapy, a panel under the ICMR, first wrote to Bansal in April this year after he uploaded an outline of his proposed study to the Clinical Trials Registry: India, a database maintained by the ICMR.1
The study plans to use stem cells from brain dead patients, biopeptides from a US company named BioQuark, and transcranial laser stimulation on patients who have been certified brain dead after traumatic brain injuries.
Bansal’s study has not been cleared by the Indian health ministry’s screening committee, which examines all proposals involving international collaboration. The ICMR has also pointed out that clinical trials involving stem cells should follow the rules prescribed by the Central Drugs Standards Control Organisation (CDSCO), the country’s regulatory agency for drugs and clinical trials.
In his email response to the ICMR, Bansal said that the agency was “unnecessarily obstructive” and that neither the ICMR nor the CDSCO should have any say in his trial because it involves brain dead patients. He has shared with the ICMR a note that he has had from the CDSCO saying that the regulatory agency has “no existing guidance or documentation” for “stem cell testing on brain dead subjects.”
Indian regulations demand that clinical trials are preceded by regulators’ scrutiny of pre-clinical (animal) studies and safety studies in the country of origin—in this case, the US, where the biopeptides are being procured.
Geeta Jotwani, a deputy director general of the ICMR, told The BMJ: “If his contention, however wrong, is that brain death may be reversible, even from his own perspective, he’s then dealing with living patients. So this trial has to follow all the prescribed rules.”
The controversy has emerged amid the ICMR’s longstanding concerns about unregulated private clinics that offer stem cell therapies for patients with health disorders such as autism, diabetes, and stroke, among others.
The ICMR’s guidelines allow the routine clinical use of stem cells from bone marrow exclusively for blood disorders. “All other applications of stem cells are experimental procedures and are viewed as research to be done under rules for clinical trials,” Jotwani said.
Bansal said that he had written to the ICMR and the CDSCO to ask why they have not cracked down on such unregulated clinics. He added, “I’m working only with brain dead patients—why is the ICMR questioning me?”
The ICMR has no regulatory powers to curb doctors’ activities. “That responsibility lies with the Medical Council of India (MCI),” Jotwani said. “We have brought unregulated stem cell practices to the notice of the MCI, we’ve asked for action against doctors engaged in such practices, but there has been no action.”
Many across the medical community have said that there was nothing in adequately peer reviewed medical literature to justify the study Bansal had proposed.
Roop Gursahani, a senior neurologist at the Hinduja Hospital in Mumbai, told The BMJ: “This [proposal] sounds bizarre. There are well defined criteria and procedures for diagnosis and certification of brain death. When brain death is properly determined, reversal is impossible.”
Gursahani, among others, had also expressed concern about the proposal’s ethical repercussions, including its likely impact on family members of brain dead patients and India’s organ transplant programme.
Bansal said that he planned to recruit only brain dead patients whose families have turned down requests for organs. Doctors fear that such a proposal might give family members false hopes that patients declared brain dead can be brought back to life.