Restoring Function in TBI with Stem Cell Therapy: Bijan Nejadnik, MD

"SB623, at this point in our clinical trials, has achieved improvement in the patient's function and improvement in motor impairment. Therefore, we think that the treatment will biologically change the brain parenchyma brain cells in order to improve the patient's functioning in a much more drastic and fundamental way than what they can achieve with just rehab.”

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

Researchers found 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. The LS mean difference was 6.0 (95% CI, 0.3–1.8; P = .04) between SB623 and control (LS mean improvement, 2.3; SE, 2.5). In the SB623 group, 39.1% reached a clinically meaningful improvement of ≥10 points on FMSS compared to 6.7% of controls (P = .039).

NeurologyLive reached out to Bijan Nejadnik, MD, chief medical officer, SanBio, to learn more about SB623 and its potential to restore function in TBI. Nejadnik discussed how SB623 could fill the void of disease-modifying therapies for TBI.

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