RECRUITING

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

Conditions

Spinal Cord Injury Cervical Spinal Cord Injury Thoracic Spinal Cord Injury, Acute Spinal Cord Injury Spinal Cord Injury, Chronic DOSED Subacute spinal cord injury Oligodendrocyte Progenitor Cell Chronic spinal cord injury Stem Cell Transplant Cervical spinal cord injury Thoracic spinal cord injury Paralysis Quadriplegia Tetraplegia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED)

Quick Facts

Study Start:2025-06-30

Study Completion:2037-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06841770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 C-4 to T-10 occurring 21 to 42 days prior to LCTOPC1 injection 3. For subjects with chronic injury, ISNCSCI NLI from C-4 to T-10 and more than 30 days without clinical improvement from last assessment, occurring 1 to 5 years prior to LCTOPC1 injection 4. Individuals must have at least one upper extremity ISNCSCI key muscle with at least 1/5 strength 5. 18 through 65 years of age, inclusive, at time of consent 6. Single injury with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring 7. Informed consent for this protocol must be provided and documented (i.e., signed ICF) 8. Able to participate in an elective surgical procedure to inject LCTOPC1 21 days or later following SCI 9. Female subjects of child-bearing potential must agree to the use of contraception for 1 year following LCTOPC1 injection; male subjects must agree to use contraception to prevent pregnancy in any female partners of child-bearing potential for 1 year following LCTOPC1 injection	1. SCI due to penetrating trauma 2. Traumatic anatomical transection, laceration, or inadequate decompression of the spinal cord based on prior surgery or MRI 3. Any concomitant injury that interferes with the performance, interpretation, or validity of neurological examinations, such as multiple spinal cord lesions, brachial/lumbar plexus injury, cauda equina injury or traumatic brain injury 4. Subjects with a cavity structure that would preclude successful transplantation, as identified on MRI, which may include septations or irregularities in tissue structure 5. Persons with syringomyelia, defined as those with progressively enlarging cysts on T2-weighted images associated with neurological decline 6. Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised 7. Organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression 8. Need for mechanical support of ventilation (ventilator, continuous positive airway pressure \[CPAP\], bi-level positive airway pressure \[BiPAP\]), excluding supplemental oxygen, at baseline 9. History of any malignancy (except non-melanoma skin cancers). For cancers in remission for more than five years, enrollment is allowed with concurred documented approval of principal investigator, oncologist, and Sponsor's medical monitor prior to enrollment 10. Pregnant or nursing women 11. Subjects with an implanted spinal cord stimulator (SCS), whether temporary or permanent.

Inclusion Criteria

Exclusion 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 C-4 to T-10 occurring 21 to 42 days prior to LCTOPC1 injection
3. For subjects with chronic injury, ISNCSCI NLI from C-4 to T-10 and more than 30 days without clinical improvement from last assessment, occurring 1 to 5 years prior to LCTOPC1 injection
4. Individuals must have at least one upper extremity ISNCSCI key muscle with at least 1/5 strength
5. 18 through 65 years of age, inclusive, at time of consent
6. Single injury with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
7. Informed consent for this protocol must be provided and documented (i.e., signed ICF)
8. Able to participate in an elective surgical procedure to inject LCTOPC1 21 days or later following SCI
9. Female subjects of child-bearing potential must agree to the use of contraception for 1 year following LCTOPC1 injection; male subjects must agree to use contraception to prevent pregnancy in any female partners of child-bearing potential for 1 year following LCTOPC1 injection

1. SCI due to penetrating trauma
2. Traumatic anatomical transection, laceration, or inadequate decompression of the spinal cord based on prior surgery or MRI
3. Any concomitant injury that interferes with the performance, interpretation, or validity of neurological examinations, such as multiple spinal cord lesions, brachial/lumbar plexus injury, cauda equina injury or traumatic brain injury
4. Subjects with a cavity structure that would preclude successful transplantation, as identified on MRI, which may include septations or irregularities in tissue structure
5. Persons with syringomyelia, defined as those with progressively enlarging cysts on T2-weighted images associated with neurological decline
6. Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
7. Organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
8. Need for mechanical support of ventilation (ventilator, continuous positive airway pressure \[CPAP\], bi-level positive airway pressure \[BiPAP\]), excluding supplemental oxygen, at baseline
9. History of any malignancy (except non-melanoma skin cancers). For cancers in remission for more than five years, enrollment is allowed with concurred documented approval of principal investigator, oncologist, and Sponsor's medical monitor prior to enrollment
10. Pregnant or nursing women
11. Subjects with an implanted spinal cord stimulator (SCS), whether temporary or permanent.

Contacts and Locations

Study Contact

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

CONTACT

442-287-0082

ClinicalTrials@lineagecell.com

Study Locations (Sites)

University of California, San Diego

La Jolla, California, 92037

United States

Collaborators and Investigators

Sponsor: Lineage Cell Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30

Study Completion Date2037-06-30

Study Record Updates

Study Start Date2025-06-30

Study Completion Date2037-06-30

Terms related to this study

Keywords Provided by Researchers

Spinal Cord Injury
DOSED
Subacute spinal cord injury
Oligodendrocyte Progenitor Cell
Chronic spinal cord injury
Stem Cell Transplant
Cervical spinal cord injury
Thoracic spinal cord injury
Paralysis
Quadriplegia
Tetraplegia

Additional Relevant MeSH Terms

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