Clinical Phase IIB Trial of Oxycyte Perflurocarbon in Severe Human Traumatic Brain Injury
Abstract
In October of 2010, the Principal Investigator of this DOD funded award traveled to Ft. Detrick, Maryland and gave a presentation to 12 members of the CDMRP staff concerning the status of the project with perfluorocarbons in severe human traumatic brain injury. The project was placed on hold, based upon a decision by the Food and Drug Administration not to allow a clinical trial with the perfluorocarbon oxycyte to be performed within the United States. In accordance with FDA recommendations, however, Oxygen BioTherapeutics, the company that manufactures oxycyte, performed a dose escalation clinical trial in Switzerland and Israel and the first batch of results in the first cohort of patients was obtained and proved to be satisfactory. Based upon these facts, and on the recommendation of the scientific program officer in the DOD, Dr. Charmaine Richmond, a request for a no cost extension to this project was submitted. A revised statement of work was also submitted, effectively changing the project from a human clinical trial to an animal study.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2011
- Accession Number
- ADA553815
Entities
People
- M. R. Bullock
Organizations
- University of Miami