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Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02302157
Recruitment Status : Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Asterias Biotherapeutics, Inc.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Number of adverse events within 1 year (365 days) that are related to AST-OPC1 injection [ Time Frame: One Year ]

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 at 30, 60, 90, 180, 270, and 365 days after injection of AST-OPC1 [ Time Frame: One Year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
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

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
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
Asterias Biotherapeutics, Inc.
Investigators
Study Director: Edward D Wirth III, MD, PhD Asterias Biotherapeutics

Responsible Party: Asterias Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02302157     History of Changes
Other Study ID Numbers: AST-OPC1-01
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Asterias Biotherapeutics, 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:
Wounds and Injuries
Spinal Cord Injuries
Spinal Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Back Injuries