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NCT Number: NCT05975424

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Southern California, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Diagnostic Test

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

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: Up to 15 years after AST-OPC1 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.

  2. Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1

    Time frame: Up to 5 years after AST-OPC1 injection

    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.

  3. Changes at the injection site as monitored by MRI

    Time frame: Up to 5 years after AST-OPC1 injection

    MRI scans will monitor the brain and cervical spine for any possible long-term changes that could be related to AST-OPC1

Secondary outcomes

  1. Changes in neurologic function as assessed by the ISNCSCI

    Time frame: Up to 5 years after AST-OPC1 injection

    Subject baseline results will be compared against changes in motor and sensory examination results

Sponsors and collaborators

Lead sponsor

Lineage Cell Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2033
Study completion
2033
First posted
Aug 3, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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