Safety Study of GRNOPC1 in Spinal Cord Injury

A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01217008

Enrollment

Registered

2010-10-08

Start date

2010-10-31

Completion date

2013-07-31

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury, GRNOPC1

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).

Interventions

BIOLOGICALGRNOPC1

One injection of 2 million GRNOPC1 cells.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Safety	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.

Secondary

Measure	Time frame	Description
Neurological function	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026