LTFU Study of Subjects With Cervical SCI Who Received AST-OPC1

Spinal Cord Injuries Clinical Trial

Official title:

A Long-term Follow-up Study of Subjects With Cervical Spinal Cord Injuries Who Received AST-OPC1 in Protocol AST-OPC1-01

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05975424
• Other study ID #: AST-OPC1-02
• Status: Active, not recruiting
• Start date: June 13, 2018
• Est. completion date: January 14, 2033

Study information

• Verified date: August 2023
• Source: Lineage Cell Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the main study AST-OPC1-01.

Description:

Study AST-OPC1-02 is a Phase 1/2a open-label, multi-center long term follow-up (LTFU) study for twenty-five (25) subjects with cervical SCI that were administered AST-OPC1 cells in the main dose-escalation study AST-OPC1-01. The purpose of this study is to monitor long-term safety in subjects for 15 years post AST-OPC1 administration.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: January 14, 2033
• Est. primary completion date: January 14, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Subjects who received AST-OPC1 under Study AST-OPC1-01

• Reconfirmation of consent for long-term follow-up

Exclusion Criteria:

•Subjects who, for geographic or compliance reasons, are inappropriate candidates for participation in a long-term follow-up study in the opinion of the Investigator

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Shepherd Center	Atlanta	Georgia
United States	RUSH University Medical Center	Chicago	Illinois
United States	University of Southern California	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Stanford University	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lineage Cell Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 AST-OPC1 injection
Primary	Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1	Summary statistics will be tabulated for chemistry and hematology laboratory parameter results and change from baseline to Year 5, as applicable, by cohort and overall. A table counting abnormal flags based on the respective lab's reference ranges by time point will be generated for each cohort and overall. At each visit, for each parameter, the number of subjects with low, normal, high, and clinically significant assessments will be tabulated.	Up to 5 years after AST-OPC1 injection
Primary	Changes at the injection site as monitored by MRI	MRI scans will monitor the brain and cervical spine for any possible long-term changes that could be related to AST-OPC1	Up to 5 years after AST-OPC1 injection
Secondary	Changes in neurologic function as assessed by the ISNCSCI	Subject baseline results will be compared against changes in motor and sensory examination results	Up to 5 years after AST-OPC1 injection

External Links

•   A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury