Safety Study of GRNOPC1 in Spinal Cord Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01217008
• Date of registration: 06/10/2010
• Prospective Registration: No
• Primary sponsor: Lineage Cell Therapeutics, Inc.
• Public title: Safety Study of GRNOPC1 in Spinal Cord Injury
• Scientific title: A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury
• Date of first enrolment: October 2010
• Target sample size: 5
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01217008
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Cord Injury

Intervention(s)

Biological: GRNOPC1

Primary Outcome(s)

Safety [Time Frame: One year]

Secondary Outcome(s)

Neurological function [Time Frame: One year]

Secondary ID(s)

CP35A007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors