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Tests treatment safety and results for Spinal Cord Injury Cervical
Official title A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
ClinicalTrials.gov ID: NCT06841770
What this study is testing
What is OPC1?
OPC1 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for spinal cord injury cervical.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 10 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) or sensory incomplete, traumatic SCI (ASIA Impairment Scale B)
- For people with subacute injury, International Standards for Neurological Classification of SCI (ISNCSCI) Neurological Level of Injury (NLI) from C-4...
- For people 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...
- Individuals must have at least one upper extremity ISNCSCI key muscle with at least 1/5 strength
- 18 through 65 years of age, inclusive, at time of consent
You likely can't join 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...
- people with a cavity structure that would preclude successful transplantation, as identified on MRI, which may include septations or irregularities...
- 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
See the full eligibility criteria
- Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) or sensory incomplete, traumatic SCI (ASIA Impairment Scale B)
- For people 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 people 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
- 18 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 people of child-bearing potential must agree to the use of contraception for 1 year following LCTOPC1 injection; male people must agree to use contraception to prevent pregnancy in any female partners of...
- 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...
- people 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...
- Pregnant or nursing women
- people with an implanted spinal cord stimulator (SCS), whether temporary or permanent.
The study team makes the final eligibility decision.
Where it's taking place
- Downey, California, United States
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Downey, California, United States; La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.