Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
5 participants
INTERVENTIONAL
2010-10-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GRNOPC1
Subjects who receive an injection of GRNOPC1
GRNOPC1
One injection of 2 million GRNOPC1 cells.
Interventions
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GRNOPC1
One injection of 2 million GRNOPC1 cells.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Lineage Cell Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University/Santa Clara Valley Medical Center
Palo Alto/San Jose, California, United States
Shepherd Center
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital
Baltimore, Maryland, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CP35A007
Identifier Type: -
Identifier Source: org_study_id
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