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Trial record 1 of 1 for:    NCT02302157
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Dose Escalation Study of AST-OPC1 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: NCT02302157
Recruitment Status : Completed
First Posted : November 26, 2014
Results First Posted : July 13, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Lineage Cell Therapeutics, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injury Spine Injury Spinal Cord Trauma Biological: AST-OPC1 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
Study Start Date : March 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection [ Time Frame: One Year ]
    Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection


Secondary Outcome Measures :
  1. Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1 [ Time Frame: One Year ]

    The scale is based on the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) that measures the severity of Spinal cord injury. The data was collected per time point during the first year (30,60,90,180,270,365). The 365-days time point was pre-specified as Secondary Outcome Measure. High score means better outcome. Units are "Scores on a scale".

    The score is divided to motor scale (0-100) and sensor scale (0-224).

    Motor scale is divided to subscale of upper extremity (0-50) and lower extremity (0-50).

    Upper and lower extremity are divided to subscale of Right (0-25) + Left (0-25).

    Each upper & lower extremity is divided to subscale of 5 motor nerve function (0-5).

    Sensor scale is divided to subscale of light touch (0-112) and pin prick (0-112).

    light touch and pin prick are divided to subscales of Right (0-56) + Left (0-56).

    Each right and left light touch and pin prick are divided to subscales of 28 sensor nerve function (0-2)



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3
  • 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

Major Exclusion Criteria:

  • SCI due to penetrating trauma
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302157


Locations
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United States, California
Univ. of California at San Diego
La Jolla, California, United States, 92093
Rancho Los Amigos/USC
Los Angeles, California, United States
Stanford University/Santa Clara Valley Medical Center
San Jose, California, United States, 95128
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Thomas Jefferson University/Magee Rehabilitation
Philadelphia, Pennsylvania, United States, 19107
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Lineage Cell Therapeutics, Inc.
Investigators
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Study Director: Edward D Wirth III, MD, PhD Asterias Biotherapeutics
  Study Documents (Full-Text)

Documents provided by Lineage Cell Therapeutics, Inc.:
Study Protocol  [PDF] July 7, 2017
Statistical Analysis Plan  [PDF] October 3, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lineage Cell Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02302157    
Other Study ID Numbers: AST-OPC1-01
First Posted: November 26, 2014    Key Record Dates
Results First Posted: July 13, 2021
Last Update Posted: July 14, 2021
Last Verified: June 2021
Keywords provided by Lineage Cell Therapeutics, Inc.:
Cervical spinal cord injury
AST-OPC1
SCiStar
OPC1
Neural cell
Trauma spinal cord
stemcell transplant
 Cervical spine injury
Paralysis
Quadriplegia
Tetraplegia
Spine injury
oligodendrocyte progenitor cell
Subacute spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Back Injuries