Ireland
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Active, not recruiting Observational

LTFU Study of Subjects Who Received GRNOPC1

NCT05919563 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2011-10-06
Last updated
2024-08-21

Condition(s) studied

Spinal Cord Injuries

Investigational drug(s) / intervention(s)

Magnetic Resonance Imaging (MRI)

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007. Exclusion Criteria: * There are no exclusion criteria for this LTFU study.

Primary outcome measure(s)

  • 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 sites (3)

FacilityCityRegionStatus
Stanford University Palo Alto California
Shepherd Center Atlanta Georgia
Northwestern Medical Group Evanston Illinois
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05919563 on ClinicalTrials.gov ↗ ← All trials in the USA