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

Phase 2Not Yet RecruitingNCT06981338

Institut Guttmann10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries (SCI)Spinal Cord Injury

Interventions

Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)COMBINATION_PRODUCT

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 technique, paired with standardised neurorehabilitation. As the first clinical study evaluating this specific combined therapy for chronic spinal cord injury (AIS A-C grades), safety monitoring incorporates regular cerebrospinal fluid analysis to assess potential immune responses.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI

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).

Time frame: Baseline through Month 12 post-treatment

Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy

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 (%).

Time frame: From baseline to week 18.

Secondary Outcomes

Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Motor Score

Change in motor function measured by the American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Motor Score, which evaluates voluntary muscle strength across 10 key muscle groups (0-5 points per muscle, total range 0-100). Higher scores indicate better motor function. Unit of Measure: Points on American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Motor Scale.

Time frame: Baseline to Month 12

Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Light Touch Sensory Score

Change in light touch sensation measured by the American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Light Touch Sensory Score (0-112 points, tested across 28 dermatomes). Higher scores indicate better sensory function. Unit of Measure: Points on American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Light Touch Scale.