Safety Study of GRNOPC1 in Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Asterias Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01217008
First received: October 6, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).


Condition Intervention Phase
Spinal Cord Injury
Biological: GRNOPC1
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered.


Secondary Outcome Measures:
  • Neurological function [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The secondary endpoint is neurological function as measured by sensory scores and lower extremity motor scores on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations.


Enrollment: 5
Study Start Date: October 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GRNOPC1
Subjects who receive an injection of GRNOPC1
Biological: GRNOPC1
One injection of 2 million GRNOPC1 cells.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels
  • Last fully preserved neurological level from T-3 through T-11
  • From 18 through 65 years of age at time of injury
  • Single spinal cord lesion
  • 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 11 days following injury
  • Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI

Major Exclusion Criteria:

  • SCI due to penetrating trauma
  • Traumatic anatomical transection or laceration of the spinal cord
  • Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations
  • Inability to communicate effectively with neurological examiner
  • Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
  • History of any malignancy
  • 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: NCT01217008

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, California
Stanford University/Santa Clara Valley Medical Center
Palo Alto/San Jose, California, United States
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital
Baltimore, Maryland, United States
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
United States, Wisconsin
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Asterias Biotherapeutics, Inc.
  More Information

No publications provided

Responsible Party: Asterias Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01217008     History of Changes
Other Study ID Numbers: CP35A007
Study First Received: October 6, 2010
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Asterias Biotherapeutics, Inc.:
Spinal Cord Injury
GRNOPC1

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014