A clinical trial using human neural stem cells for the treatment of cervical spinal cord injury is beginning at the Miller School of Medicine. The University of Miami institution is associated with the Ryder Trauma Center at Jackson Memorial Medical Center, a Level I adult and pediatric trauma center.
The Pathway Study is the first clinical trial designed to evaluate the safety and efficacy of transplanting tissue-derived stem cells into patients with traumatic injury to the cervical spinal cord. The trial will use HuCNS-SC cells, purified human neural stem cells developed by StemCells, Inc., according to a press release from The Miami Project to Cure Paralysis.
The trial will be conducted as a randomized, controlled, single-blind study and efficacy will be primarily measured by assessing motor function according to the ISNCSCI. The primary efficacy outcome will focus on change in upper extremity strength as measured in the hands, arms and shoulders.
Preclinical studies have shown that HuCNS-SC cells engraft, migrate, differentiate into the three major CNS cell types (neurons, astrocytes and oligodendrocytes) and possess the ability to survive long-term with no evidence of tumor formation or adverse effects, according to a company press release. Data has shown that transplanted HuCNS-SC cells can persist even after immunosuppression has been discontinued.
The principal investigator of the study is Allan D. Levi, MD, PhD, professor of neurological surgery at the Miller School of Medicine. In October 2013, Levi performed the world’s first nerve graft using a combination of patient nerve and patient Schwann cells to repair traumatic injury to the sciatic nerve. Read More
