Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Frequency and Severity of Adverse Events Related to the Delivery Device or Injection Procedure Through 30 Days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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 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
排除标准
- •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.
研究组 & 干预措施
LCTOPC1
Open Label Single Injection of LCTOPC1 at a Single Time Point
干预措施: OPC1 (Biological)
结局指标
主要结局
Frequency and Severity of Adverse Events Related to the Delivery Device or Injection Procedure Through 30 Days
时间窗: One month after LCTOPC1 injection
Frequency and severity of the MI PSD System or injection procedure related adverse events (AEs) through 30 days (1 month).
次要结局
- 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)