Guttmann NeuroRecovery - Viability, Safety, and Efficacy of Intrathecal Wharton's Jelly Mesenchymal Stem Cells and Transcutaneous Spinal Cord Stimulation in Chronic Spinal Cord Injury Rehabilitation: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI
研究概览
简要总结
This clinical trial primarily aims to evaluate the safety and feasibility of a combined therapeutic approach for chronic spinal cord injury (SCI). The study will investigate whether the combination of intrathecal Wharton's jelly mesenchymal stem cells and transcutaneous spinal cord stimulation (tSCS) is safe and viable in individuals with chronic traumatic SCI.
The trial will enrol 10 participants aged 16-70 with traumatic SCI (cervical or thoracic levels C1-T12) classified as ASIA Impairment Scale A-C, who are 1-5 years post-injury. Participants will receive three intrathecal injections of Wharton's jelly mesenchymal stem cells, each containing 30 million viable cells (±30%), administered intrathecally at the L3-L4 level. This cellular therapy will be combined with transcutaneous spinal cord stimulation and intensive neurorehabilitation.
Participants will undergo comprehensive assessments over a 12-month follow-up period to monitor safety, feasibility, and secondarily to evaluate potential improvements in motor, sensory, and autonomic functions. Additional annual follow-up will continue for 2 years after study completion to evaluate long-term safety.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 16-70 years (parental consent required for 16-18-year-olds)
- •Single traumatic spinal cord injury (AIS A-C) at C1-T12 levels
- •Chronic injury (1-5 years post-injury)
- •Stable medical condition with life expectancy >2 years
- •Ability to attend follow-up visits and comply with all study procedures
- •Written informed consent (and parental consent for minors)
- •Sufficient cognitive capacity to understand the study
- •For women of childbearing potential: use of effective contraception (hormonal, intrauterine device, barrier methods, sterilization, or post-menopausal status >1 year)
排除标准
- •Severe comorbidities (e.g., cardiovascular instability, active infections)
- •Individuals requiring mechanical ventilation
- •Contraindications for tSCS (e.g., implanted devices)
- •Pregnancy or breastfeeding
- •Neurodegenerative diseases
- •Significant haematological/biochemical abnormalities
- •Active or recent (≤5 years) malignancy without complete remission
- •Positive serology for HIV, hepatitis B virus, hepatitis C virus, or syphilis
- •Communication barriers (language, aphasia)
- •Concurrent participation in another clinical trial (within 30 days)
- •Recent intrathecal medication or immunosuppressants (within 60 days)
- •Multi-level spinal lesions or lesions >3 spinal segments on MRI
- •Contraindications for lumbar puncture
- •Planned spinal surgery within 24 months
- •Inability to participate in rehabilitation
- •Known allergies to stem cell preparation components
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI
时间窗: Baseline through Month 12 post-treatment
Safety assessment evaluating: 1. Neurological worsening (≥1-grade decline on the American Spinal Injury Association (ASIA) Impairment Scale \[AIS\], grades A-E, where higher grades indicate better function). 2. Cerebrospinal fluid (CSF) abnormalities (e.g., pleocytosis, elevated protein). 3. Procedure-related complications (e.g., post-lumbar puncture headache, infection). Unit of Measure: Composite binary outcome (presence/absence of any TEAE).
Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy
时间窗: From baseline to week 18.
Feasibility assessment measuring adherence to: 1. Scheduled intrathecal WJ-MSC administrations (3 doses at 6-week intervals). 2. Concomitant tSCS-assisted neurorehabilitation sessions (18 weeks). Unit of Measure: Percentage of completed interventions vs. planned (%).
次要结局
- Change in Motor Evoked Potential (MEP) Latency(Baseline to Month 12.)
- Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Motor Score(Baseline to Month 12)
- Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Light Touch Sensory Score(Baseline to Month 12.)
- Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Pinprick Sensory Score(Baseline to Month 12.)
- Change in Autonomic Control(Baseline to Month 12.)
- Change in Motor Evoked Potential (MEP) Amplitude(Baseline to Month 12.)
- Change in Somatosensory Evoked Potential (SSEP) Amplitude(Baseline to Month 12.)
- Change in Somatosensory Evoked Potential (SSEP) Latency(Baseline to Month 12.)