Safety Study of GRNOPC1 in Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217008
• Other study ID #: CP35A007
• Status: Completed
• Phase: Phase 1
• Start date: October 2010
• Est. completion date: July 2013

Study information

• Verified date: January 2014
• Source: Lineage Cell Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Biological:
• GRNOPC1
One injection of 2 million GRNOPC1 cells.

Locations

Country	Name	City	State
United States	Shepherd Center	Atlanta	Georgia
United States	University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern University	Chicago	Illinois
United States	The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Stanford University/Santa Clara Valley Medical Center	Palo Alto/San Jose	California
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lineage Cell Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neurological function	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.	One year