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NCT05919563 Clinical Trial

LTFU Study of Subjects Who Received GRNOPC1

Spinal Cord Injuries Clinical Trial

Official title:
Long Term Follow-up of Subjects Who Received GRNOPC1

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05919563
Other study ID # CP35A008
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 6, 2011
Est. completion date December 12, 2026

Study information
Verified date June 2023
Source Lineage Cell Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5
Est. completion date December 12, 2026
Est. primary completion date December 12, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging (MRI)
Observational study; annual MRI for first 5 years only to monitor changes in the injection site

Locations
Country Name City State
United States Shepherd Center Atlanta Georgia
United States Northwestern Medical Group Evanston Illinois
United States Stanford University Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Lineage Cell Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

McKenna SL, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth E, Fessler RG. Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury. J Neurosurg Spine. 2022 Apr 1:1-10. doi: 10.3171/2021.12.SPINE21622. O — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and severity of adverse events (AEs) 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. Up to 15 years after GRNOPC1 injection
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