CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
AST-OPC1biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02302157
NCT02302157Phase 2Completed
CompareCT.gov

A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury

Lineage Cell Therapeutics, Inc.·interventional·Posted Nov 26, 2014·Updated Jul 14, 2021

In Brief

A Phase 2 clinical trial evaluating AST-OPC1 for Cervical Spinal Cord Injury and 2 related conditions. Completed, enrolled 25 participants across 9 sites.

Detailed Summary

The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Spinal Cord Injury, Spine Injury, Spinal Cord Trauma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 26, 2014
Enrollment StartMar 1, 2015
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.6 years ago

Interventions

AST-OPC1biological

One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent