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OPC1

Phase 1

Spinal Cord Injury Cervical | Monoclonal antibody | Other |Lineage Cell Therapeutics, Inc.|Last Updated: Feb 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06841770A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord InjuryPHASE1 RECRUITING 10 — — Jun 30, 2025Jun 30, 2037Feb 12, 20262 United States
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Study Endpoints
Primary Endpoints
Frequency and Severity of Adverse Events Related to the Delivery Device or Injection Procedure Through 30 Days
One month after LCTOPC1 injection

Frequency and severity of the MI PSD System or injection procedure related adverse events (AEs) through 30 days (1 month).

Secondary Endpoints
Frequency and Severity of Adverse Events Related to LCTOPC1 and/or the Concomitant Immunosuppression Through 90 Days
Three months after LCTOPC1 injection
Incidence of MRI Findings Indicative of Deterioration or Safety-Related Changes at 90 Days
Three months after LCTOPC1 injection
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LCTOPC1EXPERIMENTALOpen Label Single Injection of LCTOPC1 at a Single Time Point
Interventions
NameTypeDescription
OPC1BIOLOGICALOne injection of 10 million LCTOPC1 cells will be delivered to the target injection site of the damaged spinal tissue.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) or sensory incomplete, traumatic SCI (ASIA Impairment Scale B) 2. For subjects with subacute injury, International Standards for Neurological Classification of SCI (ISNCSCI) Neurological Level of Injury (NLI) from...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06841770primaryCompletionDate: changed
LOWMay 24, 2026NCT06841770studyFirstPostDate: changed