Though the findings come with a considerable caveat — they have yet to be published in a peer-reviewed journal — the lead investigator of a controversial brain reanimation study using “living cadavers” is reporting some dramatic results.
Himanshu Bansal, MD, who is conducting the research at Anupam Hospital in Rudrapur, India, for Revita Life Sciences, described some preliminary results in an email interview with IRB Advisor. This was after a press release cited very encouraging initial findings, including minor observations on blood pressure changes, response to painful stimuli, eye opening, and finger movements.
“These reflexes clearly demonstrate that the person is not brain dead,” Bansal said in the email. “We confirmed it by EEG, which showed improved electrical activity. One of the patients even came off of a ventilator. We feel the patients will first land in a persistent vegetative state, and from there we will attempt to bring them to a useful conscious state. We are sharing soon our early results through peer-reviewed publication.”
Though it is approved only for research in India, the study is registered on ClinicalTrials.gov as a “Nonrandomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multimodality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury.” No results were reported on the site as this story was filed, and it lists the estimated study completion date as July 2018. Bioquark Inc. in Philadelphia still is listed as one of the sponsors, and an official there confirmed the trial is ongoing after it ran into a regulatory snafu in India.
“Revita is running things in India, but Bioquark is still a part of the project,” said Ira S. Pastor, BS, MBA, Bioquark CEO. “There was a bit of a local battle that put things on hold for several months. The study was inappropriately removed from the Indian Council of Medical Research (ICMR) database. However, the ICMR has no regulatory oversight on such research in India, and the group that actually does, the Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India, had no objection to the program progressing, and finally issued a letter to Revita regarding this.”
Thus the study continues, with Bansal subjecting the research subjects to interventions that include stem cells, biologics, laser therapy, and nerve stimulation. (For more information on the study, see the story in the July 2016 issue of IRB Advisor.)
“We can’t say as of now if the changes are due to stem cells, median nerve stimulation, or laser, or if it is just because of prolonged observation and natural recovery rate,” Bansal said.
Subjects between the ages of 15 and 65 that have been declared brain dead from a traumatic brain injury are being recruited from area hospitals. The living cadavers must not be indicated for organ donation, have no cranial implants, and cannot be pregnant. As approved by the IRB in India, informed consent must come from family members of the research subject.
The study was originally questioned for delving into the gray area between life and death, but the main ethical and legal constraint is that one cannot work with living cadavers in research that involves harvesting organs, Pastor said.
Bansal still holds out hope that the study will lead to some breakthrough in regenerative therapeutics, while raising profound questions about the line between biological life and death.
“This research will open the door to review the concept of irreversibility of cell death,” he said. “When should we declare irreversible cell death? Up until what time frame can it be reversed? It will definitely help in treating patients with comas and other neurological diseases.”