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

October 6, 2010
January 6, 2014
October 2010
July 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01217008 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Safety Study of GRNOPC1 in Spinal Cord Injury
A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injury
Biological: GRNOPC1
One injection of 2 million GRNOPC1 cells.
Experimental: GRNOPC1
Subjects who receive an injection of GRNOPC1
Intervention: Biological: GRNOPC1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01217008
CP35A007
Yes
Asterias Biotherapeutics, Inc.
Asterias Biotherapeutics, Inc.
Not Provided
Not Provided
Asterias Biotherapeutics, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP