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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-13

Study Completion Date

2033-01-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01

Subjects treated with AST-OPC1 in the initial dosing study AST-OPC1-01 will be followed for 15-year long-term safety monitoring

Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Magnetic Resonance Imaging (MRI)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No