LCTOPC1 Delivery Device for Spinal Cord Injury (DOSED Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Lineage Cell Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-65 with traumatic spinal cord injuries (SCI) at certain levels of the spine, occurring from 21 days to 5 years prior. Participants must have some arm muscle strength and be able to undergo surgery. Women who can get pregnant and men must agree to use contraception post-treatment.

Inclusion Criteria

I have a complete or incomplete spinal cord injury from trauma.

I can move at least one key muscle in my arm slightly.

I am between 18 and 65 years old.

Exclusion Criteria

My spinal cord injury was caused by a penetrating injury.

I have had a spinal injury or surgery that didn't properly relieve pressure on my spinal cord.

I don't have injuries that could affect nerve function tests.

I do not have any organ damage or diseases that make surgery or immunosuppression too risky.

My MRI shows I can't have a successful transplant due to cavity issues.

I have syringomyelia with worsening symptoms.

I need a machine to help me breathe, not just oxygen.

Participant Groups

The DOSED study tests a new device's safety in delivering LCTOPC1 cell therapy directly into the injured spinal cord area. The goal is to replace or support damaged cells, potentially improving function and quality of life after SCI.

1Treatment groups

Experimental Treatment

Group I: LCTOPC1Experimental Treatment1 Intervention

Open Label Single Injection of LCTOPC1 at a Single Time Point