SanBio Co Inc announces the start of a Phase 2 clinical trial of regenerative stem cell medicine SB623 for patients affected by traumatic brain injury. The trial, which will enroll 52 participants, will also include Japanese patients.
The trial, named STEMTRA (“Stem Cell Therapy for Traumatic Brain Injury”), is designed to study the safety and efficacy of SB623 cell therapy in treating patients with chronic motor impairments following traumatic brain injury. It will be conducted across approximately 25 clinical sites in the United States and five sites in Japan.
A news release from Mountain View, Calif-headquartered SanBio Co Ltd defines SB623 cells as modified allogeneic mesenchymal stem cells, derived from bone marrow stromal cells isolated from healthy adult donors. When administered into neural tissue, SB623 cells promote recovery from injury by triggering the brain’s natural regenerative ability.
Previously, SanBio completed a US-based Phase 1/2a clinical trial for SB623 in patients with chronic motor impairments 6 months to 5 years following an ischemic stroke. The results suggested its potential to improve motor function following a stroke. Based on these results, a Phase 2b randomized double blind clinical trial of 156 subjects began enrollment in December 2015 for the stroke indication. The STEMTRA trial extends the evaluation of SB623 to patients afflicted by TBI, the release notes.
“I’m very glad that SB623 can advance to a clinical development phase in Japan following the clinical trial in the United States,” says Takehiko Kaneko, head of Clinical Development in Japan at SanBio, in the release.
“I am grateful for the early and enthusiastic support. We will proceed with the clinical development of SB623 and confirm its safety and efficacy, so that we can bring help to patients suffering from ongoing disability as soon as possible,” Kaneko adds.
[Source(s): SanBio Co Inc, Business Wire]