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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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

Eligibility

Primary outcome measure(s)

• Incidence and severity of adverse events (AEs) — 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.
• Changes from baseline greater than 1.5x or 2x in chemistry and hematology panel results over 5 years after injection of AST-OPC1 — 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.
• Changes at the injection site as monitored by MRI — 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

Trial sites (6)

More Lineage Cell Therapeutics, Inc. trials in the USA

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