What is LCTOPC1 studying for spinal cord injury?

LCTOPC1 is being studied to evaluate the safety and usefulness of a new delivery device that injects cell therapy into the spinal cord to potentially improve quality of life and function in people with traumatic spinal cord injuries. This research is led by Lineage Cell Therapeutics, Inc. and focuses on patients with cervical or thoracic injuries.

Who may be eligible for this spinal cord injury clinical trial?

Adults aged 18 to 65 with specific types of traumatic spinal cord injuries (complete sensorimotor or sensory incomplete) in the cervical or thoracic spine may be eligible. Participants must have their injury either 21 to 42 days old or between 1 and 5 years old, with at least some upper extremity muscle strength. Please review eligibility criteria for more details.

Is there any cost to participate in this spinal cord injury clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 65Years

All Genders

ID06841770

Safety Study of a New Delivery Device Injecting LCTOPC1 Cell Therapy for Adults with Cervical or Thoracic Spinal Cord Injuries

Led by Lineage Cell Therapeutics, Inc. · Updated on 2026-02-12

Participants Needed

Research Sites

516 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and usefulness of a new delivery device designed to inject LCTOPC1, a cell therapy, into the spinal cord of people with spinal cord injuries SCI. LCTOPC1 aims to replace or support cells lost or damaged due to trauma, with the goal of improving quality of life and helping restore or enhance function in individuals with cervical or thoracic SCI. This Phase 1b, open-label, multi-center study focuses on both subacute and chronic SCI patients with specific injury types and locations. The study involves a one-time injection of 10 million LCTOPC1 cells administered via the novel delivery device directly to the injured spinal cord tissue. Participants include those with subacute injuries occurring 21 to 42 days before treatment and those with chronic injuries from 1 to 5 years prior. The first four participants will be enrolled sequentially after safety criteria are met. The injection is given during an elective surgical procedure, and the study monitors safety over a long-term period. Participants will undergo close monitoring for safety, including assessments of adverse events related to the device and injection procedure up to 30 days, and additional evaluations of adverse events related to LCTOPC1 and immunosuppression up to 90 days. MRI scans will assess any changes in spinal cord condition at 90 days. The study plans to follow participants for up to 10 years after treatment to track long-term safety and outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Sensorimotor complete (AIS-A) or sensory incomplete (AIS-B) traumatic spinal cord injury
Subacute injury with neurological level from C4 to T10 occurring 21 to 42 days before injection
Chronic injury with neurological level from C4 to T10 and no clinical improvement 1 to 5 years before injection
At least one upper extremity key muscle with strength of 1/5 or more
Age between 18 and 65 years at time of consent
Single injury with clear visualization of spinal cord injury site for safety monitoring
Ability to provide informed consent
Ability to undergo elective surgery for LCTOPC1 injection at least 21 days after injury
Agreement to use contraception for 1 year after injection if of child-bearing potential

You will not qualify if you...

Spinal cord injury caused by penetrating trauma
Anatomical transection, laceration, or inadequate spinal cord decompression
Other injuries interfering with neurological exams, such as multiple spinal cord lesions, plexus injury, cauda equina injury, or brain injury
Presence of cavity structures preventing transplantation, including septations or irregular tissue
Syringomyelia with progressive cyst enlargement and neurological decline
Inability to communicate effectively with neurological examiners
Organ damage or systemic illness posing surgical or immunosuppression risk
Need for mechanical ventilation support (excluding supplemental oxygen)
History of malignancy except certain skin cancers, unless approved after remission
Pregnancy or nursing
Implanted spinal cord stimulator device, temporary or permanent

Research Team

Reference Study ID Number: LCTOPC1-SCI-03 https://lineagecell.com/products-pipeline/opc1/

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