Stem Cell Therapy for TBI: Masahito Kawabori, MD, PhD

“I would like physicians to just wait a little longer for the coming of a new treatment which will bring about a new field in neurosurgery. Stem cell therapy is just around the corner. So, I'm really excited to launch this new field of treatments.”

The STEMTRA trial (NCT02416492), a 1-year, double-blind, randomized, surgical sham-controlled, phase 2 trial, recently investigated implantation of allogeneic modified bone marrow-derived mesenchymal stromal/stem cells (MSCs) developed by SanBio, dubbed SB623. Data suggest that implantation of SB623 is well-tolerated and efficacious in treating individuals with traumatic brain injury (TBI).

Among the study’s investigators was Masahito Kawabori, MD, PhD, associate professor, Hokkaido University, who saw that patients treated with SB623 improved by a least squares (LS) mean of 8.3 (standard error [SE], 1.4) at 6 months from baseline on the Fugl-Meyer Motor Scale (FMSS) score compared to an LS mean improvement of 2.3 (SE, 2.5) in the control group. The LS mean difference was 6.0 (95% CI, 0.3–1.8; P = .04) between SB623 and control. A clinically meaningful improvement of ≥10 points on FMSS was reached in 39.1% of the SB623 pooled group versus 6.7% of controls (P = .039).

NeurologyLive reached out to Kawabori to learn more about TBI and the potential of SB623 to allow patients to regain function. Kawabori also discussed trials investigating SB623 for other conditions and his excitement for the emerging field of stem cell therapy.

REFERENCE

Kawabori M, Weintraub AH, Imai H, et al. Cell therapy for chronic TBI: Interim analysis of the randomized controlled STEMTRA trial. Neurology. Published online January 4, 2021. doi: 10.1212/WNL.0000000000011450