Safety Study of GRNOPC1 in Spinal Cord Injury
This study is ongoing, but not recruiting participants.
Sponsor:
Geron Corporation
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT01217008
First received: October 6, 2010
Last updated: January 9, 2013
Last verified: January 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Biological: GRNOPC1 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury |
Resource links provided by NLM:
Further study details as provided by Geron Corporation:
Primary Outcome Measures:
- Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Neurological function [ Time Frame: One year ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GRNOPC1
Subjects who receive an injection of GRNOPC1
|
Biological: GRNOPC1
One injection of 2 million GRNOPC1 cells.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Major Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217008
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States | |
| United States, California | |
| Stanford University/Santa Clara Valley Medical Center | |
| Palo Alto/San Jose, California, United States | |
| United States, Georgia | |
| Shepherd Center | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital | |
| Baltimore, Maryland, United States | |
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States | |
| United States, Wisconsin | |
| The Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Geron Corporation
More Information
No publications provided
| Responsible Party: | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT01217008 History of Changes |
| Other Study ID Numbers: | CP35A007 |
| Study First Received: | October 6, 2010 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Geron Corporation:
|
Spinal Cord Injury GRNOPC1 |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013