Spinal Cord Injury Clinical Trial
Official title:
The Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute Spinal Cord Injury (SCI)
The purpose of this study is to assess the safety of autologous human Schwann cells (ahSC)
transplantation in subjects with subacute SCI.
For humans with subacute SCI, we hypothesize that axons might show improved function if
myelin repair is induced with the implantation of ahSC. In addition spinal cord cavitation
may be reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects.
Schwann cells are excellent candidates for transplantation into humans with SCI. Large
numbers of ahSC can be derived for autologous implantation after a minor surgery for
peripheral nerve harvesting, and purification and expansion of the cells in culture.
Autologous cells offer important safety advantages that include no need for immune
suppression, minimal risk of disease transfer, and a low risk of tumorigenicity.
Since 1990, scientists at the Miami Project to Cure Paralysis have generated extensive
preclinical data suggesting Schwann cell transplantations are successful in rodents with SCI.
The most recent work has focused on contusive injury models that are relevant to human
injury. They have also been largely responsible for developing an efficient method for
procuring large, essentially pure populations of human Schwann cells from adult peripheral
nerve.
The rationale for implantation of ahSC in people with acute SCI is based on the evidence that
Schwann cells are neuroprotective and are capable of myelinating axons. Using mitogen
expanded human Schwann cells in SCID mice and athymic female nude rats demonstrated that
human Schwann cells can survive and are capable of enhancing axonal regeneration and forming
myelin after transplantation in animals with sciatic nerve transection or thoracic spinal
cord transection. The proposed clinical trial will advance knowledge about the safety and
feasibility of a cell-based treatment strategy for human SCI.
This Phase 1 clinical trial will employ an open label, unblinded, nonrandomized and
non-placebo controlled dose-escalation design to evaluate the safety of transplantation of
ahSC transplantation in subjects with subacute SCI.
A sural nerve harvest will occur within 30 days post-injury. Standard-of-care medical
treatment and rehabilitation will proceed while the cells are being processed in a cGMP
facility. No later than 72 days post-injury, the ahSC product will be administered via a
single injection into the cavity of the spinal cord lesion.
Safety and efficacy assessments will be performed at week 1 and 2 post-transplantation and 2,
6, and 12 months post-transplantation.
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