Traumatic brain injury (TBI) can result in motor impairments that persist indefinitely. Longitudinal follow-up of patients with severe TBI with motor impairment indicates that recovery occurs primarily in the first six months post-trauma1. This suggests that patients with motor impairments persisting for more than six months after the trauma may endure a life-long burden of disability.
The STEMTRA ("STEM cell therapy for TRAumatic brain injury") study, a Phase II clinical trial, is designed to evaluate the efficacy and safety of a genetically modified adult stem cell therapy, SB623, which is administered directly to the injured brain through a neurosurgical procedure. Based on the one-year follow up results from a similar open-label study in stroke patients2,3,4, the hypothesis is that this therapy is well tolerated and may increase the potential for further functional recovery in TBI patients with persistent motor impairment.
Key eligibility criteria:
- Are age 18 or older, male or female
- Have focal brain lesion from TBI and corresponding motor impairment
- Are 1-5 years post injury
To learn about SB623, please visitwww.san-bio.com. Tel: 650-625-8965. An IRB-approved questionnaire for a prescreening registry is available at: http://tbistemcellstudy.ucsf.edu/.
For more information about STEMTRA, visit https://clinicaltrials.gov/ct2/show/NCT02416492.
Contact: Mena Niakian, Director of Clinical Operations: mena.niakian@san-bio.com; Jerry Liu, Head of Clinical Development, North America, jerry.liu@san-bio.com
References:
1. Walker WC, Pickett TC. Motor impairment after severe traumatic brain injury: A longitudinal multicenter study. Journal of rehabilitation research and development. 2007;44:975-982
2. Steinberg GK, et. al., Clinical outcomes of transplanted modified bone marrow-derived mesenchymal stem cells in stroke: A Phase 1/2a Study. Manuscript submitted to Stroke
3. Bates D, et. al., Clinical improvement in motor function following intracranial injection of modified bone marrow-derived mesenchymal stem cells (SB623) in ischemic stroke patients with chronic motor deficits. Poster presentation accepted International Society for Stem Cell Research, June, 2016; San Francisco
4. Liu WJ, et. al., preliminary safety of intracranial implantation of modified bone marrow-derived mesenchymal stem cells (SB623) in ischemic stroke patients with chronic motor deficits: a phase 1/2A study. Poster presentation accepted International Society for Stem Cell Research, June, 2016; San Francisco.