Safety Study of GRNOPC1 in Spinal Cord Injury
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01217008 |
Recruitment Status :
Completed
First Posted : October 8, 2010
Last Update Posted : June 18, 2020
|
Sponsor:
Lineage Cell Therapeutics, Inc.
Information provided by (Responsible Party):
Lineage Cell Therapeutics, Inc.
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | October 6, 2010 | ||
First Posted Date ICMJE | October 8, 2010 | ||
Last Update Posted Date | June 18, 2020 | ||
Study Start Date ICMJE | October 2010 | ||
Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: One year ] 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.
|
||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
Neurological function [ Time Frame: One year ] 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.
|
||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Safety Study of GRNOPC1 in Spinal Cord Injury | ||
Official Title ICMJE | A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury | ||
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). | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||
Condition ICMJE | Spinal Cord Injury | ||
Intervention ICMJE | Biological: GRNOPC1
One injection of 2 million GRNOPC1 cells.
|
||
Study Arms ICMJE | Experimental: GRNOPC1
Subjects who receive an injection of GRNOPC1
Intervention: Biological: GRNOPC1
|
||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
5 | ||
Original Estimated Enrollment ICMJE |
10 | ||
Actual Study Completion Date ICMJE | July 2013 | ||
Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Major Inclusion Criteria:
Major Exclusion Criteria:
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01217008 | ||
Other Study ID Numbers ICMJE | CP35A007 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Lineage Cell Therapeutics, Inc. | ||
Original Responsible Party | Regenerative Medicine Clinical Operations, Geron Corporation | ||
Current Study Sponsor ICMJE | Lineage Cell Therapeutics, Inc. | ||
Original Study Sponsor ICMJE | Geron Corporation | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Lineage Cell Therapeutics, Inc. | ||
Verification Date | January 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |