InVivo Therapeutics is teaming up with the University of Miami Miller School of Medicine’s Miami Project to Cure Paralysis to develop new treatments for spinal cord injuries (SCIs) that combine the organizations’ respective biopolymer scaffolds and cellular therapies. The Miami Project’s IND-pending Schwann cell platform will be leveraged in the alliance. InVivo and the Miami Project will jointly own resulting IP, and InVivo will retain the right of first offer to license and commercialize resulting products worldwide.
Invivo’s biopolymer scaffolds are designed to mimic properties of the extracellular matrix within the spinal cord and so facilitate proliferation and survival of implanted cells. The firm claims preclinical trials have demonstrated that implanting the resulting biopolymer devices either alone, combined with drugs, or seeded with human neural cells, promotes post-SCI neural survival and minimizes scarring. An IND filing with FDA to start trials with the scaffolds in an acute SCI setting is imminent, according to Invivo.
“To date, InVivo has been focused primarily on acute spinal cord injury research,” comments Frank Reynolds, InVivo CEO. “This partnership will allow us to advance these technologies to the chronic spinal cord injury population.”
The Miami Project says trials have demonstrated that Schwann cell transplantation promotes axonal regeneration and remyelination following SCI in animals. When combined with other cells or drugs, the implanted Schwann cells also help minimize damage, remyelinate, and promote recovery of motor function. The organization projects submitting an IND application to FDA later this year to enable the start of clinical trials.
“InVivo’s biopolymer scaffoldings are novel tissue-engineering solutions that may serve to improve functional recovery and promote the proliferation and survival of cellular therapies such as Schwann cells at the site of injury," adds W. Dalton Dietrich, III, Ph.D., The Miami Project’s scientific director. "We see significant potential in the natural synergies from combining these treatment approaches.”
InVivo’s approach to treating SCIs focuses on protecting the spinal cord and preventing secondary injury, rather than on regeneration. The resulting platform technologies are designed to minimizing tissue damage sustained following acute injury and promote neural plasticity of the spared healthy tissue, which may result in full or partial functional recovery.
The firm aims to exploit its technologies to develop three implantable or injectable product types: a biocompatible polymer scaffolding device to treat acute wound SCI, a biocompatible hydrogel for local controlled release of methylprednisolone to treat acute SCI, and a biocompatible scaffolding device seeded with autologous human neural stem cells to treat acute and chronic SCI.