A Phase I/II, Randomized, Double-blind, Placebo-controlled, Parallel, 2-arms Clinical Trial to Assess the Safety and Efficacy of Intrathecal Administration of WJ-MSC in Chronic Traumatic Cervical Incomplete Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to either the active treatment (2 doses of intrathecal WJ-MSC 3 months apart) or to placebo (2 intrathecal infusions, 3 months apart). Thereafter, patients will be followed-up for 12 months for safety and efficacy assessment.
详细描述
Double-blind, randomized, placebo-controlled, multicenter clinical trial that will include 18 patients affected with chronic traumatic incomplete cervical spinal cord injury who will be randomized 1:1, stratified by center, to one of the 2 treatment arms of the study: WJ-MSC / WJ-MSC (at a dose of 1E6 ± 30% live cells / Kg of weight) or Placebo / placebo. Medication will be administered intrathecally at day 1 and at 3 months. The main objective of the trial is to assess safety at a 12-month follow-up. Secondary objectives include the evaluation of efficacy through clinical response, electrophysiological changes, questionnaires of functionality and quality of life, as well as the presence of anti-HLA antibodies and donor cellularity in the cerebrospinal fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Active treatment and placebo will be released using the same syringe and blinded in a way that it is no possible to distinguish one to the other.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single spinal cord injury lesion caused by trauma
- •Affected cord segments between C1 and T1, confirmed by magnetic resonance
- •Incomplete lesion (ASIA B, C or D)
- •Chronic disease state (between 1 and 5 years after the injury)
- •Patients from 18 to 70 years of age, both sexes
- •Life expectancy > 2 years
- •Residence near the center during study participation and confidence that the patient will attend the follow-up visits
- •Given informed consent in writing
- •Patient is able to understand the study and its procedures
排除标准
- •Mechanic ventilation
- •Penetrating trauma affecting the spinal cord
- •Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
- •Planned spinal surgery within subsequent 12 month after entering the trial
- •Neurodegenerative diseases
- •Significant abnormal laboratory tests that contraindicates patient's participation in the study
- •Neoplasia within the previous 5 years, or without complete remission
- •Patient with communication difficulties
- •Simultaneous participation in another clinical trial or treated with an investigational medicinal product the previous 30 days, that could interfere in the results of the study
- •Previous treatment with and advanced Therapy Medicinal Product (cell therapy)
- •Contraindication for lumbar punction
- •Contraindication or inability to follow a rehabilitation program
- •Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- •The patient does not accept to be followed-up for a period that could exceed the clinical trial length
研究组 & 干预措施
WJ-MSC (XCEL-UMC-BETA)
Pre-filled syringe with 4 ± 1 mL containing WJ-MSC in a balanced saline solution supplemented with human albumin.
干预措施: WJ-MSC (XCEL-UMC-BETA) (Drug)
Placebo
Pre-filled syringe with 4 ± 1 mL containing a balanced saline solution supplemented with human albumin
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: At 12 month follow-up
Adverse events
次要结局
- Modified Ashworth scale for spasticity(At 6 and 12 month follow-up)
- Handgrip Strength(At 6 and 12 month follow-up)
- Electrical pain threshold perception(At 6 and 12 month follow-up)
- Walking index for spinal cord injury (WISCI II)(At 6 and 12 month follow-up)
- Motor evoked potentials(At 6 and 12 month follow-up)
- Numerical scale for neuropathic pain assessment(At 6 and 12 month follow-up)
- American Spinal Injury Association (ASIA) impairment scale(At 1, 3, 4, 6 and 12 month follow-up)
- Somatosensory evoked potentials(At 6 and 12 month follow-up)
- Psychological general well-being index (PGWBI)(At 12 month follow-up)
- Hospital Anxiety and Depression Scale (HADS)(At 12 month follow-up)
- Community Integration Questionaire (CIQ-IG)(At 12 month follow-up)
- Spinal Cord Independence Measure III (SCIM III)(At 6 and 12 month follow-up)
- World Health Organization Quality of life questionnaire (WHOQOL-BREF)(At 6 and 12 month follow-up)
- AntiHLA antibodies in cerebrospinal fluid (CSF)(At 7 days and at 1 month follow-up after each infusion)
- Detection of donor cells in CSF(At 7 days after each infusion)