Safety Study of GRNOPC1 in Spinal Cord Injury

NCT01217008 | Completed Phase 1 DMC

• 1 other identifier: CP35A007
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 7

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).

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; GRNOPC1

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  One year

Secondary Outcomes (1)

• Neurological function

  One year

Study Arms (1)

GRNOPC1

EXPERIMENTAL

Subjects who receive an injection of GRNOPC1

Biological: GRNOPC1

Interventions

GRNOPC1 BIOLOGICAL

One injection of 2 million GRNOPC1 cells.

GRNOPC1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lineage Cell Therapeutics, Inc.: lead

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

Stanford University/Santa Clara Valley Medical Center

Palo Alto/San Jose, California, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital

Baltimore, Maryland, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 18, 2020

Record last verified: 2014-01

Locations

US (7)