A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury

Part of paid clinical trials in Downey, California.

Sponsor
Lineage Cell Therapeutics, Inc.
Study ID
NCT06841770
Phase
PHASE1
Status
Recruiting
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Conditions

  • Spinal Cord Injury
  • Spinal Cord Injury Cervical
  • Spinal Cord Injury Thoracic
  • Spinal Cord Injury, Acute
  • Spinal Cord Injury, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • OPC1 — BIOLOGICAL
    One injection of 10 million LCTOPC1 cells will be delivered to the target injection site of the damaged spinal tissue.

Study Details

The DOSED clinical study evaluates the safety and utility of a novel delivery device to deliver LCTOPC1, a cell therapy, to the spinal cord of patients with a spinal cord injury (SCI). LCTOPC1 is designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with a goal to help improve the quality of life and restore or augment functional activity in persons suffering from a traumatic cervical or thoracic injuries.

Key Dates

Start date
Jun 30, 2025
Status verified
Feb 2026
Primary completion
Aug 10, 2027
Completion
Jun 30, 2037

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LCTOPC1
    Open Label Single Injection of LCTOPC1 at a Single Time Point

Primary Outcome Measure

Frequency and Severity of Adverse Events Related to the Delivery Device or Injection Procedure Through 30 Days [ Time Frame: One month after LCTOPC1 injection ]

Central Contacts

  • Reference Study ID Number: LCTOPC1-SCI-03 https://lineagecell.com/products-pipeline/opc1/
    442-287-8940
    [email protected]

Locations (2)

FacilityCityStateZIPSite coordinators
Rancho Research InstitueDowneyCalifornia90242
Charles Liu, MD
[email protected]
Charles Liu, MD (PRINCIPAL_INVESTIGATOR)
University of California, San DiegoLa JollaCalifornia92037
Thuy Pham
[email protected]
858-951-5303
Talyn Hughes
[email protected]
858-905-0698
Joseph Ciacci, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Rancho Research Institue· Downey, CAUniversity of California, San Diego· La Jolla, CA

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