Introduction Information of STEMTRA to Clinicians
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.