LTFU Study of Subjects Who Received GRNOPC1
Long Term Follow-up of Subjects Who Received GRNOPC1
1 other identifier
observational
5
1 country
3
Brief Summary
This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2011
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 6, 2011
CompletedFirst Submitted
Initial submission to the registry
May 24, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 12, 2026
August 21, 2024
August 1, 2024
15.2 years
May 24, 2023
August 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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
Interventions
Observational study; annual MRI for first 5 years only to monitor changes in the injection site
Eligibility Criteria
Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007
You may qualify if:
- Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Stanford University
Palo Alto, California, 94304, United States
Shepherd Center
Atlanta, Georgia, 30309, United States
Northwestern Medical Group
Evanston, Illinois, 60208, United States
Related 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;37(3):321-330. doi: 10.3171/2021.12.SPINE21622. Print 2022 Sep 1.
PMID: 35364569RESULT
Related Links
Biospecimen
Blood samples for immune response monitoring and xenotransplantation safety samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gary Hogge, DVM, MS, PhD
Lineage Cell Therapeutics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2023
First Posted
June 26, 2023
Study Start
October 6, 2011
Primary Completion (Estimated)
December 12, 2026
Study Completion (Estimated)
December 12, 2026
Last Updated
August 21, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share