Cell Therapy for Chronic TBI
Masahito Kawabori, Alan Weintraub, Hideaki Imai, Iaroslav Zinkevych, Peter McAllister, Gary K. Steinberg, Benjamin Frishberg, Takao Yasuhara, Jefferson W. Chen, Steven C. Cramer, Achal S. Achrol, Neil Schwartz, Jun Suenaga, Daniel C. Lu, I.P. Semeniv, Hajime Nakamura, Douglas Kondziolka, Dai Chida, Takehiko Kaneko, Yasuaki Karasawa, Susan Paadre, Bijan Nejadnik, Damien Bates, Anthony H. Stonehouse, R. Mark Richardson, David O. Okonkwo
Abstract
OBJECTIVE: To determine whether chronic motor deficits secondary to traumatic brain injury (TBI) can be improved by implantation of allogeneic modified bone marrow-derived mesenchymal stromal/stem cells (SB623). METHODS: SB623 cells or control. Safety was assessed in patients who underwent surgery (n = 61), and efficacy was assessed in the modified intent-to-treat population of randomized patients who underwent surgery (n = 61; SB623 = 46, control = 15). RESULTS: = 0.25). CONCLUSIONS: SB623 cell implantation appeared to be safe and well tolerated, and patients implanted with SB623 experienced significant improvement from baseline motor status at 6 months compared to controls. CLINICALTRIALSGOV IDENTIFIER: NCT02416492. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that implantation of SB623 was well tolerated and associated with improvement in motor status.