Status:
COMPLETED
Safety Study of GRNOPC1 in Spinal Cord Injury
Lead Sponsor:
Lineage Cell Therapeutics, Inc.
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 inj...
Eligibility Criteria
Inclusion
- Major
- Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation \< 5 levels
- Last fully preserved neurological level from T-3 through T-11
- From 18 through 65 years of age at time of injury
- Single spinal cord lesion
- Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 11 days following injury
- Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI
- Major
Exclusion
- SCI due to penetrating trauma
- Traumatic anatomical transection or laceration of the spinal cord
- Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations
- Inability to communicate effectively with neurological examiner
- Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
- History of any malignancy
- Pregnant or nursing women
- Body mass index (BMI) \> 35 or weight \> 300 lbs.
- Active participation in another experimental procedure/intervention
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01217008
Start Date
October 1 2010
End Date
July 1 2013
Last Update
June 18 2020
Active Locations (7)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Stanford University/Santa Clara Valley Medical Center
Palo Alto/San Jose, California, United States
3
Shepherd Center
Atlanta, Georgia, United States, 30309
4
Northwestern University
Chicago, Illinois, United States, 60611