Dipnarine Maharaj - Cancer Clinical Trial Information

Dipnarine Maharaj - Cancer Clinical Trial Information

 

Dr. Dipnarine Maharaj M.D., FACP - Medical Director - South Florida Bone Marrow Stem Cell Transplant Institute

 

 

 

South Florida Bone Marrow Stem Cell Transplant Institute (SFBMSCTI), based on a scientific collaboration with Dr Zheng Cui at Wake Forest University (WFU), has received IND (Investigational New Drug) approval from the FDA and WIRB (Western Institutional Review Board) approval to conduct a Phase I/II clinical trial using granulocytes for treatment of solid tumors in cancer patients. The clinical trial designation is 08001-BMSCTI.

 In its simplest terms the protocol involves recruiting donors with a matching ABO/Rh (blood type) to the cancer patient and a significant HLA (tissue typing) mismatch, screening them on the basis of a predetermined set of study criteria, collecting their granulocytes from their peripheral blood, and transfusion of the fresh product to the matching cancer patient. On average, it requires 5 qualified donors to yield sufficient numbers of granulocytes to treat one cancer patient. Again on average, it takes 25 willing donors to yield those 5 qualified donors. (Based on potential Patient C-H, 10 qualified donors were obtained from a pool of 47 willing donors that met the study criteria).