Набор скоро начнётся NCT06981338

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

Фаза I / Фаза II С лечением Spinal Cord Injuries (SCI) Spinal Cord Injury Traumatic Spinal Cord Injuries Spinal Cord Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs).
Кому может быть актуально: Состояния в реестре: Spinal Cord Injuries (SCI), Spinal Cord Injury, Traumatic Spinal Cord Injuries, Spinal Cord Disease. Базовые параметры: 16 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Комбинированный продукт Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)
This experimental treatment combines intrathecal administration of allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs) with transcutaneous spinal cord stimulation (tSCS) and neurorehabilitation. Participants will receive three doses of cryopreserved WJ-MSCs (30×10⁶±30% viable cells per dose) derived from umbilical cord tissue, delivered via lumbar puncture at 6-week intervals in a saline-albumin solution. The intervention includes concurrent tSCS, a non-invasive electrical stimulation te

Первичные конечные точки

Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI [Срок оценки: Baseline through Month 12 post-treatment]
Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy [Срок оценки: From baseline to week 18.]

Вторичные конечные точки (8)

Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Motor Score [Срок оценки: Baseline to Month 12]
Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Light Touch Sensory Score [Срок оценки: Baseline to Month 12.]
Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Pinprick Sensory Score [Срок оценки: Baseline to Month 12.]
Change in Autonomic Control [Срок оценки: Baseline to Month 12.]
Change in Motor Evoked Potential (MEP) Amplitude [Срок оценки: Baseline to Month 12.]
Change in Motor Evoked Potential (MEP) Latency [Срок оценки: Baseline to Month 12.]
Change in Somatosensory Evoked Potential (SSEP) Amplitude [Срок оценки: Baseline to Month 12.]
Change in Somatosensory Evoked Potential (SSEP) Latency [Срок оценки: Baseline to Month 12.]

Критерии участия

Критерии включения

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)