LTFU Study of Subjects Who Received GRNOPC1

• Sponsor: Lineage Cell Therapeutics, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05919563
• Collaborator: (none)
• Enrollment: 5
• Locations: 3
• Anticipated Duration (Months): 182.2
• Patients Per Site: 1.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Diagnostic Test: Magnetic Resonance Imaging (MRI)

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 Design

• Study Type: Observational
• Actual Enrollment: 5 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Long Term Follow-up of Subjects Who Received GRNOPC1
• Actual Study Start Date: Oct 6, 2011
• Anticipated Primary Completion Date: Dec 12, 2026
• Anticipated Study Completion Date: Dec 12, 2026

Arms and Interventions

Arm	Intervention/Treatment
Subjects treated with GRNOPC1 in the initial dosing study CP35A007 Subjects treated with GRNOPC1 in the initial dosing study CP35A007 will be followed for 15-year long-term safety monitoring	Diagnostic Test: Magnetic Resonance Imaging (MRI); Observational study; annual MRI for first 5 years only to monitor changes in the injection site

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304
2	Shepherd Center	Atlanta	Georgia	United States	30309
3	Northwestern Medical Group	Evanston	Illinois	United States	60208

Sponsors and Collaborators

• Lineage Cell Therapeutics, Inc.

Investigators

• Study Chair: Gary Hogge, DVM, MS, PhD, Lineage Cell Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury

Publications

None provided.

• Responsible Party: Lineage Cell Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05919563
• Other Study ID Numbers: CP35A008
• First Posted: Jun 26, 2023
• Last Update Posted: Jun 26, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

No Results Posted as of Jun 26, 2023