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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs).
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries (SCI), Spinal Cord Injury, Traumatic Spinal Cord Injuries, Spinal Cord Disease. Basic parameters: 16 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Interventions
- Combination product 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
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI [Time frame: Baseline through Month 12 post-treatment]
- Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy [Time frame: From baseline to week 18.]
Secondary outcome measures (8)
- Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Motor Score [Time frame: Baseline to Month 12]
- Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Light Touch Sensory Score [Time frame: Baseline to Month 12.]
- Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Pinprick Sensory Score [Time frame: Baseline to Month 12.]
- Change in Autonomic Control [Time frame: Baseline to Month 12.]
- Change in Motor Evoked Potential (MEP) Amplitude [Time frame: Baseline to Month 12.]
- Change in Motor Evoked Potential (MEP) Latency [Time frame: Baseline to Month 12.]
- Change in Somatosensory Evoked Potential (SSEP) Amplitude [Time frame: Baseline to Month 12.]
- Change in Somatosensory Evoked Potential (SSEP) Latency [Time frame: Baseline to Month 12.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Institut Guttmann: Hospital de Neurorehabilitació — Badalona
Identifiers
NCT: NCT06981338 · GNR-SCI-01 · 2025-521877-14-00