Functionalized Peptide Gels and Schwann Cells for Repair of the Injured Spinal Cord
Abstract
Spinal cord injury (SCI) affects 42,000 Wounded Warriors, their Families, and their caregivers, placing a significant burden and cost on their health care unless new therapies can be developed that can restore function and quality of life. At the forefront of regenerative medicine, cell transplantation provides the means to bridge the injured spinal cord for support of axon regeneration and reconnection, as well as replace lost neural tissue. Through CDMRP SCIRP TRA support, we have translated (from TRL3 to TRL6) autologous human Schwann cells (ahSCs) from the benchtop to two phase 1 clinical trials in sub-acute and chronic human SCI. The first trial showed that ahSC transplantation was feasible and safe in six sub-acute thoracic AIS A subjects; the second, that ahSC transplantation was safe and feasible in chronic thoracic and cervical subjects, AIS A-C. In preparation for phase 2 efficacy trials in SCI, we seek to enhance ahSC repair by overcoming two main limitations: (1) survival in the injury milieu and (2) the growth inhibitory effects of the glial scar. To accomplish this goal, we formed a collaboration between U. Miami and G4M to optimize the cell delivery vehicle for ahSCs by using a sheer, thinning, functionalized, scaffolding matrix fabricated from self-assembly peptides to improve localized cell delivery, protection, and conformal filling of the cavity. G4M’s patented technology results from a decade of engineering, optimization, and characterization of its Peptide Materials Platform, providing materials that are simple to manufacture and easy to administer in a surgical setting. Importantly, in 2022 Gel4Med received FDA approval for use of their peptide gel platform in humans for wound repair. Studies will be conducted to systematically improve the effectiveness of Gel4Rep for enhancing SC mediated repair in SCI as measured by histopathology, biochemistry, and functional efficacy on sensorimotor and autonomic outcomes. Generated preclinical data will be used in support of phase 2 trials using combined G4Rep and ahSCs.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252311084
Entities
People
- Damien D Pearse
Organizations
- United States Army
- University of Miami