Safety Study of GRNOPC1 in Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GRNOPC1
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, GRNOPC1
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- Stanford University/Santa Clara Valley Medical Center
- Shepherd Center
- Northwestern University
- University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital
- Thomas Jefferson University Hospital
- The Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GRNOPC1
Arm Description
Subjects who receive an injection of GRNOPC1
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01217008
First Posted
October 6, 2010
Last Updated
June 16, 2020
Sponsor
Lineage Cell Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01217008
Brief Title
Safety Study of GRNOPC1 in Spinal Cord Injury
Official Title
A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lineage Cell Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 injuries (SCI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, GRNOPC1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GRNOPC1
Arm Type
Experimental
Arm Description
Subjects who receive an injection of GRNOPC1
Intervention Type
Biological
Intervention Name(s)
GRNOPC1
Intervention Description
One injection of 2 million GRNOPC1 cells.
Primary Outcome Measure Information:
Title
Safety
Description
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
Secondary Outcome Measure Information:
Title
Neurological function
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Stanford University/Santa Clara Valley Medical Center
City
Palo Alto/San Jose
State/Province
California
Country
United States
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
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Safety Study of GRNOPC1 in Spinal Cord Injury
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