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Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Asterias Biotherapeutics, Inc.
Information provided by (Responsible Party):
Asterias Biotherapeutics, Inc. Identifier:
First received: November 24, 2014
Last updated: August 17, 2017
Last verified: August 2017
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 Intervention Phase
Cervical Spinal Cord Injury Spine Injury Spinal Cord Trauma Biological: AST-OPC1 Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Asterias Biotherapeutics, Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 35
Study Start Date: March 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02302157

United States, California
Univ. of California at San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Teresa Rzesiewicz    844-317-7836   
Principal Investigator: Joseph Ciacci, MD         
Rancho Los Amigos/USC Recruiting
Los Angeles, California, United States
Contact: Sheetal Desai    562-401-7020   
Contact: Sandra Oviedo    (323) 865-9873   
Principal Investigator: Charles Liu, MD, PhD         
Stanford University/Santa Clara Valley Medical Center Recruiting
San Jose, California, United States, 95128
Contact: Nhung Quach    408-885-3962   
Contact: Maria Coburn    650-736-9551   
Principal Investigator: Gary K Steinberg, MD         
Sub-Investigator: Stephen McKenna, MD         
United States, Georgia
Shepherd Center Recruiting
Atlanta, Georgia, United States, 30309
Contact: Admissions    800-743-7437   
Principal Investigator: Donald P Leslie, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary Messenger    312-563-6827   
Contact: Carol MacPherson   
Principal Investigator: Richard G Fessler, MD, PhD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Heather Cero    317-396-1298   
Principal Investigator: Eric M Horn, MD, PhD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: John Evans    314-362-3473   
Principal Investigator: Wilson Zack Ray, MD         
United States, Pennsylvania
Thomas Jefferson University/Magee Rehabilitation Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kara Pigott    215-503-9110   
Principal Investigator: James Harrop, MD         
Sub-Investigator: Guy Fried, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Charlotte Klis    414-805-7183   
Principal Investigator: Kurpad Shekar, MD, PhD         
Sponsors and Collaborators
Asterias Biotherapeutics, Inc.
Study Director: Edward D Wirth III, MD, PhD Asterias Biotherapeutics
  More Information

Responsible Party: Asterias Biotherapeutics, Inc. Identifier: NCT02302157     History of Changes
Other Study ID Numbers: AST-OPC1-01
Study First Received: November 24, 2014
Last Updated: August 17, 2017

Keywords provided by Asterias Biotherapeutics, Inc.:
Cervical spinal cord injury
Neural cell
Trauma spinal cord
stemcell transplant
Cervical spine injury
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 processed this record on September 19, 2017