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AST-OPC1

Phase 1

Cervical Spinal Cord Injury | Monoclonal antibody | Neurology |Lineage Cell Therapeutics, Inc.|Last Updated: Jul 14, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

AST-OPC1 · 1 trial · 3 indications

Phase 1 1
NCT02302157Dose Escalation Study of AST-OPC1 in Spinal Cord InjuryCervical Spinal Cord Injury
COMPLETED25 Analytics
PHASE1COMPLETED
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Cervical Spinal Cord Injury
NCT0230215725
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Study Endpoints

Primary Endpoints

Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
One Year

Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection

Secondary Endpoints

Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1
One Year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AST-OPC1EXPERIMENTALOpen label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point

Interventions

NameTypeDescription
AST-OPC1BIOLOGICALOne 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
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Eligibility Criteria

Age Range18 Years to 69 Years
SexALL
Healthy VolunteersNo
Study Sites9

Major Inclusion Criteria: * Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3 * Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5 * Last fully preserved single neurological level (SNL) from C-4 to C-7 * From 18 through 69 years of age at...

Countries:United States
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Frequently asked questions about AST-OPC1

What is AST-OPC1 used for?

AST-OPC1 is an investigational therapy being developed for the treatment of cervical spinal cord injury. It is a monoclonal antibody designed to address this neurological condition. The drug is currently in clinical development and has not been approved for commercial use.

Who makes AST-OPC1?

AST-OPC1 is being developed by Lineage Cell Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol LCTX. Lineage Cell Therapeutics is responsible for the clinical development of this investigational therapy for cervical spinal cord injury.

What phase is AST-OPC1 in?

AST-OPC1 is in Phase 1 clinical development. It has completed a Phase 1 dose escalation study in patients with cervical spinal cord injury. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is AST-OPC1 in?

AST-OPC1 has been studied in one clinical trial, identified as NCT02302157. This was a Phase 1 dose escalation study in spinal cord injury, which has been completed. The trial enrolled 25 participants in the United States and was not randomized or blinded.

How does AST-OPC1 work?

AST-OPC1 is a monoclonal antibody, a type of biologic therapy that uses antibodies to target specific proteins in the body. However, the specific molecular target of AST-OPC1 has not been disclosed in available information.