Abstract
Background: Although many therapeutic approaches have been attempted to treat spinal cord injury, cellular transplantation offers the greatest promise in reconstituting the architecture of the damaged cord. Methods: A literature review was conducted to search for clinical trials investigating stem cells as treatment for spinal cord injury in the United States. Results: Overall, eight studies met inclusion criteria. Of the included studies, four were identified as being terminated, suspended, or not yet recruiting. Two studies were identified as currently recruiting, including one phase one trial evaluating stereotactic injections of human spinal cord-derived neural stem cells in patients with chronic spinal cord injuries, and one trial of transplantation of autologous bone marrow derived stem cells via paraspinal injections, intravenous injections, and intranasal placement. One study was identified as an active study, a phase one trial of intrathecal injection of 100 million autologous, ex-vivo expanded, adipose-derived mesenchymal stem cells. One trial that was listed as completed is a phase 1/2a, dose escalation study, investigating stereotactic injection of human embryonic stem cell derived oligodendrocyte progenitor cells. Conclusions: Although few significant publications have emerged to this point, current trial results are promising.
Highlights
The global incidence of spinal cord injury (SCI) ranges between 10.4 and 83 per million inhabitants per year [1,2]
Several trials were excluded for using non-cell-based therapies, such as Sovateltide and Methylprednisolone, for using non-stem cell-based therapies, such as transplantation of harvested Schwann cells, or for including non-human subjects
A literature search was done to identify clinical trials conducted in the United States investigating stem cell transplantation for treatment of spinal cord injury
Summary
The global incidence of spinal cord injury (SCI) ranges between 10.4 and 83 per million inhabitants per year [1,2]. Of these injuries approximately half result in complete neurologic injury and approximately 33% result in tetraplegia [1,2]. Two studies were identified as currently recruiting, including one phase one trial evaluating stereotactic injections of human spinal cord-derived neural stem cells in patients with chronic spinal cord injuries, and one trial of transplantation of autologous bone marrow derived stem cells via paraspinal injections, intravenous injections, and intranasal placement. Conclusions: few significant publications have emerged to this point, current trial results are promising
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