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.
LCTOPC1-SCI-03 DOSED study is a Phase 1b, open-label, multi-center, device safety study designed to assess the safety of a novel delivery device for administering a one-time injection of LCTOPC1. The study will enroll 3-5 participants with subacute (21 to 42 days post-injury) spinal cord injuries and 3-5 participants with chronic (1 to 5 years post-injury) spinal cord injuries. Eligible participants must have either sensorimotor complete (AIS-A) or motor complete / sensory incomplete spinal cord injuries (AIS-B), located in the cervical (C4-C7) or thoracic (T1-T10) regions. The first four patients will be enrolled sequentially subsequent to meeting safety requirements. Participants will be monitored for long-term safety for up to 10 years following the administration of LCTOPC1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
One injection of 10 million LCTOPC1 cells will be delivered to the target injection site of the damaged spinal tissue.
Rancho Research Institue
Downey, California, United States
NOT_YET_RECRUITINGUniversity of California, San Diego
La Jolla, California, United States
RECRUITINGFrequency 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).
Time frame: One month after LCTOPC1 injection
Frequency and Severity of Adverse Events Related to LCTOPC1 and/or the Concomitant Immunosuppression Through 90 Days
Frequency and severity of AEs through 90 days (3 months) following injection of LCTOPC1 and/or the concomitant immunosuppression administered.
Time frame: Three months after LCTOPC1 injection
Incidence of MRI Findings Indicative of Deterioration or Safety-Related Changes at 90 Days
Incidence of MRI findings indicative of deterioration or safety-related changes at 90 days post-administration of LCTOPC1. Central radiologists will assess MRI data for the presence and severity of: (1) Intramedullary hemorrhage, CSF leak, epidural abscess, or infection; (2) Expanding cyst or mass at the injection site or elsewhere in the CNS; (3) Inflammatory lesions at the injection site or elsewhere in the CNS; (4) CSF flow obstruction. Severity will be categorized as \[mild, moderate, severe\] based on predefined radiological criteria.
Time frame: Three months after LCTOPC1 injection
Reference Study ID Number: LCTOPC1-SCI-03 https://lineagecell.com/products-pipeline/opc1/
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