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

NCT06981338 | Not Yet Recruiting Phase 1

• 2 other identifiers: GNR-SCI-012025-521877-14-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries (SCI); Spinal Cord Injury; Traumatic Spinal Cord Injuries; Spinal Cord Disease

Keywords

Mesenchymal Stem Cells; Spinal Cord Injuries; Cell- and Tissue-Based Therapy; Intrathecal Administration; Neuroplasticity; Spinal Cord Stimulation; Safety; Clinical Trials, Phase I; Electric Stimulation Therapy; Feasibility Study

Outcome Measures

Primary Outcomes (2)

• 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).

  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 (%).

  From baseline to week 18.

Secondary Outcomes (8)

• 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.

Study Arms (1)

Allogeneic WJ-MSCs + tSCS-Assisted Neurorehabilitation

EXPERIMENTAL

All participants receive three intrathecal doses of allogeneic Wharton's jelly mesenchymal stem cells (30×10⁶±30% viable cells/dose) at 6-week intervals, combined with transcutaneous spinal cord stimulation (tSCS)-assisted neurorehabilitation.

Combination Product: Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)

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.

Also known as: Transcutaneous spinal cord stimulation (tSCS)

Allogeneic WJ-MSCs + tSCS-Assisted Neurorehabilitation

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Guttmann: lead

Study Sites (1)

Institut Guttmann: Hospital de Neurorehabilitació

Badalona, Barcelona, Catalonia, 08916, Spain

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Joan Vidal Samsó, MD, PhD

CONTACT

(+34)934977700; jvidal@guttmann.com

Fernando Martins Braga, MD, MSc

CONTACT

(+34)934977700; fmartins@guttmann.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This single-arm, open-label pilot study combines intrathecal Wharton's jelly mesenchymal stem cells (3 doses of 30×10⁶±30% cells at 6week-intervals) with transcutaneous spinal cord stimulation (tSCS) in chronic SCI patients (AIS A-C, 1-5 years post-injury). The model evaluates: * Safety (AEs, neurological/immunological monitoring) * Feasibility (adherence/retention rates) * Efficacy signals (motor/sensory/autonomic improvements via ASIA, neurophysiological tests). * All participants receive active treatment with 12-month core follow-up + 2-year extended safety monitoring.

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 20, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)