LTFU Study of Subjects Who Received GRNOPC1

Active, not recruiting

• Conditions: Spinal Cord Injuries

• Registration Number: NCT05919563
• Lead Sponsor: Lineage Cell Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2011-10-06
• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-06-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2026-12-12
• Study Completion: 2026-12-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

• There are no exclusion criteria for this LTFU study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Stanford University; 🇺🇸 Palo Alto, California, United States

Shepherd Center; 🇺🇸 Atlanta, Georgia, United States

Northwestern Medical Group; 🇺🇸 Evanston, Illinois, United States