NCT06841770

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
136mo left

Started Jun 2025

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2025Jun 2037

First Submitted

Initial submission to the registry

February 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2027

Expected
9.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2037

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

February 11, 2025

Last Update Submit

February 11, 2026

Conditions

Spinal Cord Injury CervicalSpinal Cord Injury ThoracicSpinal Cord Injury, AcuteSpinal Cord InjurySpinal Cord Injury, Chronic

Keywords

Spinal Cord InjuryDOSEDSubacute spinal cord injuryOligodendrocyte Progenitor CellChronic spinal cord injuryStem Cell TransplantCervical spinal cord injuryThoracic spinal cord injuryParalysisQuadriplegiaTetraplegia

Outcome Measures

Primary Outcomes (1)

  • Frequency and Severity of Adverse Events Related to the Delivery Device or Injection Procedure Through 30 Days

    Frequency and severity of the MI PSD System or injection procedure related adverse events (AEs) through 30 days (1 month).

    One month after LCTOPC1 injection

Secondary Outcomes (2)

  • Frequency and Severity of Adverse Events Related to LCTOPC1 and/or the Concomitant Immunosuppression Through 90 Days

    Three months after LCTOPC1 injection

  • Incidence of MRI Findings Indicative of Deterioration or Safety-Related Changes at 90 Days

    Three months after LCTOPC1 injection

Study Arms (1)

LCTOPC1

EXPERIMENTAL

Open Label Single Injection of LCTOPC1 at a Single Time Point

Biological: OPC1

Interventions

OPC1BIOLOGICAL

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

LCTOPC1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) or sensory incomplete, traumatic SCI (ASIA Impairment Scale B)
  • 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
  • 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
  • Individuals must have at least one upper extremity ISNCSCI key muscle with at least 1/5 strength
  • through 65 years of age, inclusive, at time of consent
  • Single injury with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
  • Informed consent for this protocol must be provided and documented (i.e., signed ICF)
  • Able to participate in an elective surgical procedure to inject LCTOPC1 21 days or later following SCI
  • 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

You may not qualify if:

  • SCI due to penetrating trauma
  • Traumatic anatomical transection, laceration, or inadequate decompression of the spinal cord based on prior surgery or MRI
  • 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
  • Subjects with a cavity structure that would preclude successful transplantation, as identified on MRI, which may include septations or irregularities in tissue structure
  • Persons with syringomyelia, defined as those with progressively enlarging cysts on T2-weighted images associated with neurological decline
  • Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
  • Organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
  • Need for mechanical support of ventilation (ventilator, continuous positive airway pressure \[CPAP\], bi-level positive airway pressure \[BiPAP\]), excluding supplemental oxygen, at baseline
  • 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
  • Pregnant or nursing women
  • Subjects with an implanted spinal cord stimulator (SCS), whether temporary or permanent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rancho Research Institue

Downey, California, 90242, United States

NOT YET RECRUITING

University of California, San Diego

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesBronchiolitis Obliterans SyndromeParalysisQuadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

442-287-8940ClinicalTrials@lineagecell.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 24, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

August 10, 2027

Study Completion (Estimated)

June 30, 2037

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

At this time, we do not plan to share IPD from this study. As this is a Phase 1 safety study with a small sample size, the data are primarily focused on initial safety assessments and sharing IPD is not anticipated to provide significant additional value. However, summary-level results will be made available in accordance with regulatory guidelines.

Locations

US(2)