The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
One injection of 2 million GRNOPC1 cells.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University/Santa Clara Valley Medical Center
Palo Alto/San Jose, California, United States
Shepherd Center
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Safety
The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered.
Time frame: One year
Neurological function
The secondary endpoint is neurological function as measured by sensory scores and lower extremity motor scores on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations.
Time frame: One year
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University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital
Baltimore, Maryland, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States