LTFU Study of Subjects Who Received GRNOPC1

Long Term Follow-up of Subjects Who Received GRNOPC1

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05919563

Enrollment

Registered

2023-06-26

Start date

2011-10-06

Completion date

2026-12-12

Last updated

2024-08-21

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

Conditions

Spinal Cord Injuries

Brief summary

This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.

Detailed description

Study CP35A008 is a Phase 1, multi-center long term follow-up (LTFU) study for five (5) subjects with complete thoracic SCI that were administered 2 million GRNOPC1 cells in the main study CP35A007. The purpose of this study is to monitor long-term safety in subjects for 15 years post GRNOPC1 administration.

Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging (MRI)

Observational study; annual MRI for first 5 years only to monitor changes in the injection site

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007.

Exclusion criteria

* There are no

Design outcomes

Primary

Measure	Time frame	Description
Incidence and severity of adverse events (AEs)	Up to 15 years after GRNOPC1 injection	Information will be collected on all adverse events through Year 5 and on late-occurring adverse events (Years 6-15) related to any changes in neurological condition, a fever of unknown etiology, and the development of neoplasias and/or neurological disorders.

Countries

United States

Outcome results

None listed

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