India has struck off an experiment to breathe life into brain-dead accident victims from its clinical trials registry on regulatory grounds. Many term the world’s first trials of this kind as a modern take on the classical Frankenstein theory of resuscitation of the dead.
Indian Council of Medical Research (ICMR) senior official Geeta Jotwani told the Science Magazine about several regulatory lapses in the trial. These include failure to take permission from the Drug Controller General of India.
Now that ICMR has deregistered ReAnima, the Drug Controller General of India must stop the trial immediately.Jotwani
The project was a joint venture between a Philadelphia-based biotech company and a hospital in a little-known Himalayan town of Rudrapur.
According to a press release published by the two companies, the leaders of the trial were interested in learning more about how some species in nature – like amphibians, planarians and certain fish – can regenerate brain matter even after a traumatic injury. The underlying mechanics of this ability could theoretically be applied in human models.
The trial recently gained a lot of media attention when an Indian orthopedic surgeon announced plans to inject the central nervous system of around 20 brain-dead people with stem cells and give laser and median nerve stimulation. These techniques have sometimes revived patients from coma.
Bioquark, a US-based biotech firm, had agreed to supply specialised chemicals that may help regenerate brain cells. However, Dr Himanshu Bansal says ICMR is overstepping its jurisdiction and the matter rests with the drug controller.
Bioquark chief executive Ira Pastor also believes that the setback won’t stop the project. If necessary the trials may be moved outside India. “Many road blocks, no doubt, will pop up. But the project will go on,” Pastor said
The article first appeared on Sputnik International.