Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Asterias Biotherapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Asterias Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02302157
First received: November 24, 2014
Last updated: May 17, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to evaluate the safety of 3 sequential escalating doses of AST-OPC1 administered at a single time-point between 14 and 30 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: No masking
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, and 365 days after injection of AST-OPC1 [ Time Frame: One Year ]

Estimated Enrollment: 35
Study Start Date: March 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 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

  Eligibility

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-5 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 25 days following injury
  • Able to participate in an elective surgical procedure to inject AST-OPC1 14-30 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 ClinicalTrials.gov identifier: NCT02302157

Locations
United States, California
Rancho Los Amigos/USC Recruiting
Los Angeles, California, United States
Contact: Sheetal Desai    562-401-7020    sheetald@ranchoresearch.org   
Contact: Sandra Oviedo    (323) 865-9873    sandra.oviedo@health.usc.edu   
Principal Investigator: Charles Liu, MD, PhD         
Stanford University/Santa Clara Valley Medical Center Recruiting
Stanford/San Jose, California, United States, 94305
Contact: Reza Ehsanian    408-885-2153    Reza.Ehsanian@hhs.sccgov.org   
Contact: Maria Coburn    650-736-9551    cellsforSCI@stanford.edu   
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    admissions@shepherd.org   
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    Mary_Messenger@rush.edu   
Contact: Carol MacPherson       Carol_L_MacPherson@rush.edu   
Principal Investigator: Richard G Fessler, MD, PhD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Heather Cero    317-396-1298    hcero@goodmancampbell.com   
Principal Investigator: Eric M Horn, MD, PhD         
United States, Missouri
Washington University Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: John Evans    314-362-3473    evansj@wudosis.wustl.edu   
Principal Investigator: Wilson Zack Ray, MD         
United States, Pennsylvania
Thomas Jefferson University/Magee Rehabilitation Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kara Pigott    215-503-9110    Kara.Pigott@jefferson.edu   
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    cklis@mcw.edu   
Principal Investigator: Kurpad Shekar, MD, PhD         
Sponsors and Collaborators
Asterias Biotherapeutics, Inc.
Investigators
Study Director: Edward D Wirth III, MD, PhD Asterias Biotherapeutics
  More Information

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

ClinicalTrials.gov processed this record on May 25, 2017