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NCT Number: 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

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.

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Disease Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Traumatic Spinal Cord Injuries Wounds and Injuries

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institut Guttmann: Hospital de Neurorehabilitació

Badalona, Barcelona, Catalonia, 08916, Spain

Location contact

Fernando Martins Braga, MD, MSc

CONTACT

[email protected]

(+34)934977700

Joan Vidal Samsó, MD, PhD

CONTACT

[email protected]

(+34)934977700

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Transcutaneous spinal cord stimulation (tSCS)

Primary outcomes

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

    Time frame: Baseline through Month 12 post-treatment

    Safety assessment evaluating:

    • Neurological worsening (≥1-grade decline on the American Spinal Injury Association (ASIA) Impairment Scale [AIS], grades A-E, where higher grades indicate better function).
    • Cerebrospinal fluid (CSF) abnormalities (e.g., pleocytosis, elevated protein).
    • Procedure-related complications (e.g., post-lumbar puncture headache, infection).

    Unit of Measure: Composite binary outcome (presence/absence of any TEAE).

  2. Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy

    Time frame: From baseline to week 18.

    Feasibility assessment measuring adherence to:

    • Scheduled intrathecal WJ-MSC administrations (3 doses at 6-week intervals).
    • Concomitant tSCS-assisted neurorehabilitation sessions (18 weeks). Unit of Measure: Percentage of completed interventions vs. planned (%).

Secondary outcomes

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

    Time frame: Baseline to Month 12

    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.

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

    Time frame: Baseline to Month 12.

    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.

  3. Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Pinprick Sensory Score

    Time frame: Baseline to Month 12.

    Change in pinprick sensation measured by the American Spinal Injury Association (ASIA) Impairment Scale [AIS] Pinprick 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] Pinprick Scale.

  4. Change in Autonomic Control

    Time frame: Baseline to Month 12.

    Change in autonomic function (e.g., bladder, bowel, cardiovascular regulation) assessed using the International Standards to document Autonomic Function after Spinal Cord Injury (ISAFSCI). Scores range from 0 (no function) to 2 (normal function) per domain. Higher scores indicate better autonomic control.

    Unit of Measure: Autonomic Function after Spinal Cord Injury (ISAFSCI) composite score.

  5. Change in Motor Evoked Potential (MEP) Amplitude

    Time frame: Baseline to Month 12.

    Change in corticospinal tract integrity measured by Motor Evoked Potential (MEP) amplitude during transcranial magnetic stimulation. In the absence of pathological hyperexcitability, higher MEP amplitudes generally reflect better corticospinal tract integrity.

    Unit of Measure: Microvolts (µV).

  6. Change in Motor Evoked Potential (MEP) Latency

    Time frame: Baseline to Month 12.

    Change in corticospinal conduction speed measured by Motor Evoked Potential (MEP) latency during transcranial magnetic stimulation. Shorter latencies generally reflect faster, more efficient corticospinal tract conduction.

    Unit of Measure: Milliseconds (ms).

  7. Change in Somatosensory Evoked Potential (SSEP) Amplitude

    Time frame: Baseline to Month 12.

    Change in dorsal column-medial lemniscus pathway integrity measured by Somatosensory Evoked Potential (SSEP) amplitude during peripheral nerve stimulation. In the absence of pathological hyperexcitability, higher SSEP amplitudes generally reflect better somatosensory pathway integrity.

    Unit of Measure: Microvolts (µV).

  8. Change in Somatosensory Evoked Potential (SSEP) Latency

    Time frame: Baseline to Month 12.

    Change in somatosensory pathway conduction speed measured by Somatosensory Evoked Potential (SSEP) latency during peripheral nerve stimulation. Shorter latencies generally reflect faster, more efficient conduction along the dorsal column-medial lemniscus pathway.

    Unit of Measure: Milliseconds (ms).

Study contacts

Contact information is provided by the study sponsor or research team.

Fernando Martins Braga, MD, MSc

CONTACT

[email protected]

(+34)934977700

Joan Vidal Samsó, MD, PhD

CONTACT

[email protected]

(+34)934977700

Sponsors and collaborators

Lead sponsor

Institut Guttmann

Other

Registry information

Official study 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

Acronym: GNR-SCI-01

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
May 20, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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