Stem Cell Therapy for Traumatic Brain Injury?

Article

Phase 2 trial results suggest the possibility of a treatment that may regenerate brain cells following TBI.

stem cell therapy

Image ©Catalin/Adobe Stock

A possible stem cell treatment for patients with traumatic brain injury (TBI) demonstrated positive results in a recent phase 2 trial. The results were announced by the manufacturer of the investigational treatment, the SanBio Group, in a press release and were also presented at the American Association of Neurological Surgeons Annual Scientific Meeting in San Diego, California, April 13 to 17, 2019.1

The trial included 61 patients with stable chronic motor deficits caused by TBI: 46 were treated with the investigational stem cell product, SB623, and 15 underwent sham surgery as a control group. The SB623 cells were implanted directly around the site of brain injury.

Improvement was measured by the change from baseline in the Fugl-Meyer Motor Scale (FMMS) score. The scale measures changes in motor impairment, and a 10 or higher point improvement is considered a clinically meaningful threshold in acquired brain injury. Eighteen patients treated with SB623 (39.1%) reached this threshold compared with one control patient (6.7%). This difference was statistically significant (P = .044).

No new safety signals were identified. Post-operative headaches were the most common adverse events (42.6%). No significant differences were found in the rate of adverse events between patients treated with SB623 and those who received the placebo treatment (P = .25).

“The results of this study are truly groundbreaking, demonstrating the possibility of regenerating the brain following injury-a finding that could have significant implications for research in traumatic brain injury and other brain diseases,” said David O. Okonkwo, MD, PhD, Professor of Neurological Surgery and Director of the Neurotrauma Clinical Trials Center at the University of Pittsburgh, in a press statement.

For more information on stem cell therapy for other neurological disorders:

Progress for Stem Cell Transplant in MS

Stem Cell Transplantation for Parkinson Disease

Stem Cell Therapy for Migraine?

References:

1. AANS 2019: SB623 demonstrated statistically significant improvement in motor function among patients with chronic motor deficit from traumatic brain injury (TBI) [press release]. Mountain View, CA: The SanBio Group; April 16, 2019.

Recent Videos
Matthew Ku, MBBS, FRACP, RACP, FRCPA/RCPA, PhD, an associate professor and the lymphoma stream lead at St Vincent’s Hospital
Saurabh Dahiya, MD, FACP, an associate professor of medicine at Stanford University School of Medicine; as well as clinical director of Cancer Cell Therapy in the Division of Blood and Marrow Transplantation and Cell Therapy at Stanford Medicine
Shahzad Raza, MD, a hematologist/oncologist at the Cleveland Clinic
Manali Kamdar, MD, the associate professor of medicine–hematology and clinical director of lymphoma services at the University of Colorado
Shahzad Raza, MD, a hematologist/oncologist at the Cleveland Clinic
Laura Aguilar MD, PhD, the chief medical officer of Diakonos Oncology
Jamie Jacobs, PhD, the program director of the center for psychiatric oncology & behavioral sciences at Mass General Cancer Center
Laura Aguilar MD, PhD, the chief medical officer of Diakonos Oncology
Sarah Hein, PhD, the chief executive officer and cofounder of March Biosciences
Brian Kim, MBA, the chief executive officer of Mission Bio
Related Content
© 2025 MJH Life Sciences

All rights reserved.