Safety Study of GRNOPC1 in Spinal Cord Injury | NCT01217008

Studies
Safety Study of GRNOPC1 in Spinal Cord Injury

NCT01217008

Sponsor

Lineage Cell Therapeutics, Inc.

Status

Completed

Last Update Posted

Jun 18, 2020Actual

Enrollment

5Actual

Phase

Phase 1

Conditions

Spinal Cord Injury

Interventions

GRNOPC1

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Oct 6, 2010

First Submission Date that Met QC Criteria

Oct 7, 2010

First Posted Date

Oct 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2020

Last Update Posted Date

Jun 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GRNOPC1	Experimental	Subjects who receive an injection of GRNOPC1	Biological: GRNOPC1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GRNOPC1	Biological	One injection of 2 million GRNOPC1 cells.	GRNOPC1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety	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.	One year

Secondary Outcomes

Measure	Description	Time Frame
Neurological function	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.	One year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama		United States
Stanford University/Santa Clara Valley Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided