LTFU Study of Subjects Who Received GRNOPC1

Lineage Cell Therapeutics

Status: Active, not recruiting

Conditions: Spinal Cord Injuries

Treatments: Diagnostic Test: Magnetic Resonance Imaging (MRI)

Study type: Observational

Funder types: Industry

Identifiers

NCT05919563

CP35A008

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• There are no exclusion criteria for this LTFU study.

Trial design

5 participants in 1 patient group

Subjects treated with GRNOPC1 in the initial dosing study CP35A007

Description:

Subjects treated with GRNOPC1 in the initial dosing study CP35A007 will be followed for 15-year long-term safety monitoring

Treatment:

Diagnostic Test: Magnetic Resonance Imaging (MRI)