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

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01217008 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ^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
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 Arms

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

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

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

U.S. FDA-regulated Product

Not Provided

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

PRS Account

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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