Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
NCT ID: NCT02302157
Last Updated: 2021-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2015-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5
* Last fully preserved single neurological level (SNL) from C-4 to C-7
* From 18 through 69 years of age at time of injury
* Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI) scan, with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
* 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 37 days following injury
* Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days following SCI
Exclusion Criteria
* Traumatic anatomical transection or laceration of the spinal cord based on prior surgery or MRI
* Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
* Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
* Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
* History of any malignancy (except non-melanoma skin cancers)
* Pregnant or nursing women
* Body mass index (BMI) \> 35 or weight \> 300 lbs.
* Active participation in another experimental procedure/intervention
18 Years
69 Years
ALL
No
Sponsors
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Lineage Cell Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Edward D Wirth III, MD, PhD
Role: STUDY_DIRECTOR
Asterias Biotherapeutics
Locations
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Univ. of California at San Diego
La Jolla, California, United States
Rancho Los Amigos/USC
Los Angeles, California, United States
Stanford University/Santa Clara Valley Medical Center
San Jose, California, United States
Shepherd Center
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Washington University
St Louis, Missouri, United States
Thomas Jefferson University/Magee Rehabilitation
Philadelphia, Pennsylvania, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.
McKenna SL, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth E, Fessler RG. Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury. J Neurosurg Spine. 2022 Apr 1;37(3):321-330. doi: 10.3171/2021.12.SPINE21622. Print 2022 Sep 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AST-OPC1-01
Identifier Type: -
Identifier Source: org_study_id
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