Last year, two biotech companies announced that they had received institutional review board (IRB) approval for a study focused on the clinical intervention of brain death in humans. The study, entitled "Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury" (ClinicalTrials.gov Identifier NCT02742857), brought together Bioquark Inc., a Philadelphia-based life sciences company that develops proprietary combinatorial biologic products for both the regeneration and repair of human organs and tissues, as well as the reversion of a range of chronic degenerative diseases, and Revita Life Sciences, an Indian biotechnology company that develops stem cell therapies targeting areas of significant unmet or poorly met medical need.
The trial is part of Bioquark's ReAnima Project, which is described in the following video:
Click here for Video.
As initially posted on ClinicalTrials.gov (and as updated last June), the study was expected to enroll an initial 20 subjects, declared to be brain dead from a traumatic brain injury having diffuse axonal injury on MRI, and be conducted at Anupam Hospital in Rudrapur, Uttarakhand India, where Revita is headquartered. The study, which was expected to be initiated in July 2017 and completed in July 2018, had as its primary outcome the reversal of brain death as noted in clinical examination or electroencephalography (EEG). A report on STAT last summer, however, indicated that the study was experiencing some difficulties due to lack of regulatory approval in India, and that Bioquark may be looking for a new study location in Latin America.
In the press release announcing the study's approval, Bioquark and Revita noted that while human beings lack substantial regenerative capabilities in the central nervous system, many non-human species, such as amphibians, planarians, and certain fish, can repair, regenerate, and remodel substantial portions of their brain and brain stem even after critical life-threatening trauma. In addition to providing insight into human brain death, Bioquark President Dr. Sergei Paylian expects the study to "have important connections to future therapeutic development for other severe disorders of consciousness, such as coma, and the vegetative and minimally conscious states, as well as a range of degenerative CNS conditions, including Alzheimer's and Parkinson's disease."
A check of the U.S. Patent & Trademark Office patent application full text (AppFT) database identified one published application assigned to Bioquark, U.S. Patent Application Publication No. US 2014/0030244, entitled "Extracts Isolated From Electroporated Amphibian Oocytes And Use Thereof In Treating Diseases And Disorders." However, the published application, which is directed to a method for preparing a pharmaceutical composition comprising extracts of activated amphibian oocytes that can be used, inter alia, for the treatment of traumatic brain injury, was abandoned for failure to pay the issue fee. No other Bioquark or ReAnima Advanced Biosciences published U.S. applications or issued U.S. patents were identified.
