Trial record 1 of 1 for:
NCT02302157
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT02302157 |
Recruitment Status :
Completed
First Posted : November 26, 2014
Last Update Posted : July 17, 2020
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Sponsor:
Lineage Cell Therapeutics, Inc.
Information provided by (Responsible Party):
Lineage Cell Therapeutics, Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | November 24, 2014 | |||
First Posted Date ICMJE | November 26, 2014 | |||
Last Update Posted Date | July 17, 2020 | |||
Study Start Date ICMJE | March 2015 | |||
Actual Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of adverse events within 1 year (365 days) that are related to AST-OPC1 injection [ Time Frame: One Year ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Neurological function as measured by upper extremity motor scores and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations at 30, 60, 90, 180, 270, and 365 days after injection of AST-OPC1 [ Time Frame: One Year ] | |||
Original Secondary Outcome Measures ICMJE |
Neurological function as measured by upper extremity motor scores and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations at 30, 60, 90, 180, and 365 days after injection of AST-OPC1 [ Time Frame: One Year ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Dose Escalation Study of AST-OPC1 in Spinal Cord Injury | |||
Official Title ICMJE | A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury | |||
Brief Summary | The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: AST-OPC1
One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent
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Study Arms ICMJE | Experimental: AST-OPC1
Open label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point
Intervention: Biological: AST-OPC1
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
25 | |||
Original Estimated Enrollment ICMJE |
13 | |||
Actual Study Completion Date ICMJE | December 2018 | |||
Actual Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Major Inclusion Criteria:
Major Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 69 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 | NCT02302157 | |||
Other Study ID Numbers ICMJE | AST-OPC1-01 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Lineage Cell Therapeutics, Inc. | |||
Study Sponsor ICMJE | Lineage Cell Therapeutics, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Lineage Cell Therapeutics, Inc. | |||
Verification Date | July 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |