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Active, Not Recruiting

NCT Number: NCT05919563

LTFU Study of Subjects Who Received GRNOPC1

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • There are no exclusion criteria for this LTFU study.

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Diagnostic Test

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

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lineage Cell Therapeutics, Inc.

Industry

Registry information

Official study title

Long Term Follow-up of Subjects Who Received GRNOPC1

Important dates

Study start
2011
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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