Safety Study of GRNOPC1 in Spinal Cord Injury - Full Text View

Sponsor:	Geron Corporation
Information provided by (Responsible Party):	Geron Corporation
ClinicalTrials.gov Identifier:	NCT01217008

Purpose

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	Intervention	Phase
Spinal Cord Injury	Biological: GRNOPC1	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Geron Corporation:

Primary Outcome Measures:

Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
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:

Neurological function [ Time Frame: One year ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	10
Study Start Date:	October 2010
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GRNOPC1 Subjects who receive an injection of GRNOPC1	Biological: GRNOPC1 One injection of 2 million GRNOPC1 cells.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217008

Locations

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

Geron Corporation

More Information

No publications provided

Responsible Party:	Geron Corporation
ClinicalTrials.gov Identifier:	NCT01217008 History of Changes
Other Study ID Numbers:	CP35A007
Study First Received:	October 6, 2010
Last Updated:	January 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Geron Corporation:

Spinal Cord Injury
GRNOPC1

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2012