Safety Study of GRNOPC1 in Spinal Cord Injury

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Asterias Biotherapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT01217008

First received: October 6, 2010

Last updated: January 6, 2014

Last verified: January 2014

History of Changes

Tracking Information
First Received Date ^ICMJE	October 6, 2010
Last Updated Date	January 6, 2014
Start Date ^ICMJE	October 2010
Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 7, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01217008 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 7, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety Study of GRNOPC1 in Spinal Cord Injury
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Spinal Cord Injury
Intervention ^ICMJE	Biological: GRNOPC1 One injection of 2 million GRNOPC1 cells.
Study Arm (s)	Experimental: GRNOPC1 Subjects who receive an injection of GRNOPC1 Intervention: Biological: GRNOPC1
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	5
Completion Date	July 2013
Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United States
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01217008
Other Study ID Numbers ^ICMJE	CP35A007
Has Data Monitoring Committee	Yes
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Asterias Biotherapeutics, Inc.
Study Sponsor ^ICMJE	Asterias Biotherapeutics, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Asterias Biotherapeutics, Inc.
Verification Date	January 2014
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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