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Trial record 1 of 1 for:    GRNOPC1
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Safety Study of GRNOPC1 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: NCT01217008
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Lineage Cell Therapeutics, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Cord Injury Biological: GRNOPC1 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury
Study Start Date : October 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: GRNOPC1
Subjects who receive an injection of GRNOPC1
 Biological: GRNOPC1
One injection of 2 million GRNOPC1 cells.


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: One year ]
    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 :
  1. Neurological function [ Time Frame: One year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01217008


Locations
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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
Lineage Cell Therapeutics, Inc.
More Information
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Responsible Party: Lineage Cell Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01217008    
Other Study ID Numbers: CP35A007
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: January 2014
Keywords provided by Lineage Cell Therapeutics, Inc.:
Spinal Cord Injury
GRNOPC1
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System