Safety Study of GRNOPC1 in Spinal Cord Injury

Lineage Cell Therapeutics

Status and phase

Completed

Phase 1

Conditions

Spinal Cord Injury

Treatments

Biological: GRNOPC1

Study type

Interventional

Funder types

Industry

Identifiers

NCT01217008

CP35A007

Details and patient eligibility

About

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).

Enrollment

5 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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