Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury

A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Transplantation in Cervical Spinal Cord Injury

This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.

Inclusion Criteria:

• Male or female subjects age 18 to 60 years.
• Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator.
• American Spinal Injury Association Impairment Scale (AIS) Grades B or C
• Minimum of 12 weeks post-injury prior to Screening

Exclusion Criteria:

• History of penetrating SCI.
• MRI evidence of complete spinal cord interruption .
• Evidence of spinal instability, stenosis and/or persistent cord compression related to the initial trauma.
• Prior participation in another investigational study within 90 days prior to Screening.
• Previous organ, tissue, bone marrow transplantation, or gene transfer
• History of malignancy (except non-melanoma skin cancers) that require(d) radiation and/or chemotherapy