Safety Study of GRNOPC1 in Spinal Cord Injury

Phase 1

Completed

• Conditions: Spinal Cord Injury
• Interventions: Biological: GRNOPC1

• Registration Number: NCT01217008
• Lead Sponsor: Lineage Cell Therapeutics, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-01
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GRNOPC1	GRNOPC1	Subjects who receive an injection of GRNOPC1

Primary Outcome Measures

Name	Time	Method
Safety	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

Name	Time	Method
Neurological function	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.

Trial Locations

Locations (7)

Stanford University/Santa Clara Valley Medical Center; 🇺🇸 Palo Alto/San Jose, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Shepherd Center; 🇺🇸 Atlanta, Georgia, 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