Safety Study of GRNOPC1 in Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT01217008
• Recruitment Status: Completed
• First Posted: October 8, 2010
• Last Update Posted: January 7, 2014
• Sponsor: Asterias Biotherapeutics, Inc.
• Information provided by (Responsible Party): Asterias Biotherapeutics, Inc.

Tracking Information

• First Submitted Date: October 6, 2010
• First Posted Date: October 8, 2010
• Last Update Posted Date: January 7, 2014
• Study Start Date: October 2010
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 7, 2010)

Safety [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01217008 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: October 7, 2010)

Neurological function [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of GRNOPC1 in Spinal Cord Injury
• Official Title: A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Spinal Cord Injury

Intervention

Biological: GRNOPC1

One injection of 2 million GRNOPC1 cells.

Study Arms

Experimental: GRNOPC1

Subjects who receive an injection of GRNOPC1

Intervention: Biological: GRNOPC1

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 6, 2014): 5
• Original Estimated Enrollment (submitted: October 7, 2010): 10
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01217008
• Other Study ID Numbers: CP35A007
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Asterias Biotherapeutics, Inc.
• Study Sponsor: Asterias Biotherapeutics, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Asterias Biotherapeutics, Inc.
• Verification Date: January 2014