Dr. Bansal is not manipulating a cadaver, which means the patients are not quite dead: ICMR DG
Despite ethical and regulatory concerns being raised over a clinical trial to ‘revive’ brain-dead patients, the study’s principal investigator Dr. Himanshu Bansal has said that he will continue with the trial. Dr. Bansal was quoted in the British Medical Journal (BMJ), that the Indian Council of Medical Research (ICMR), nodal agency for medical research in India, was “unnecessarily obstructive”.
In May, The Hindu had reported from the trial site in Rudrapur, Uttarakhand that the world’s first trial on brain-dead patients was being conducted, taking advantage of regulatory loopholes. The project is a joint-venture between the Philadelphia-based biotech company Bioquark Inc, Revita Life Science (of which Dr. Bansal is the owner) and Anupam Hospital in Rudrapur.
The ICMR had approached Dr. Bansal stating that the trial, known as “Project ReAnima’, had to follow the guidelines laid down by the Central Drugs Standard Control Organisation (CDSCO), the country’s regulatory agency for drugs and clinical trials, when dealing with stem cells.
Responding to the regulatory agency, Dr. Bansal said the trial did not require permission from the Drug Controller General of India (DCGI) or CDSCO since his subjects were already brain-dead and this study did not have an “existing guidance or documentation” for stem cell testing.
Pointing out that Dr. Bansal was working with living patients and needed to be regulated, Dr. Soumya Swaminathan, Director General, ICMR said: “He is conducting a clinical trial and there are a number of requirements which it does not fulfil. The doctor is trying to revive brain-dead patients and is not manipulating a cadaver, which means they [brain-dead] are not quite dead. There are several ethical issues when conducting a trial of living people. These trials need some system of monitoring.”
Project ReAnima was born from “anecdotal studies” where Dr. Bansal brought back a certain degree of sensation in brain-dead patients.
The trial’s technical name is ‘First In Human Neuro-Regeneration & Neuro-Reanimation’ and the first phase will be a non-randomised, single group ‘proof of concept’ conducted at Anupam Hospital in Rudrapur.
For six weeks, after a patient is declared brain dead by any hospital in the area, Dr Bansal will study the effects of stem cell therapy, Median Nerve Stimulation and a laser therapy on him.http://www.thehindu.com/news/national/no-clearance-needed-for-clinical-trial-on-braindead-patients/article8856088.ece