Spinal Cord Injuries (SCI)Phase 1/2GNR-SCI-01NCT06981338
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 Phase 1/2 study testing Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs) in people with Spinal Cord Injuries (SCI) and Spinal Cord Injury, run by Institut Guttmann at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Spinal Cord Injuries (SCI), Spinal Cord Injury, Traumatic Spinal Cord Injuries
- What is being tested?
- Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Institut Guttmann: Hospital de Neurorehabilitació
Badalona, Barcelona, Catalonia, 08916
Joan Vidal Samsó, MD, PhD, (+34)934977700, jvidal@guttmann.com
Fernando Martins Braga, MD, MSc, (+34)934977700, fmartins@guttmann.com
About this study
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
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
- Being tested
- Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)
- 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
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)Combination product
Also called Transcutaneous spinal cord stimulation (tSCS)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI
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).
Measured: Baseline through Month 12 post-treatment
Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy
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 (%).
Measured: From baseline to week 18.
Secondary outcomes (8)
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.
Measured: 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.
Measured: Baseline to Month 12.
Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Pinprick Sensory Score
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.
Measured: Baseline to Month 12.
Change in Autonomic Control
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.
Measured: Baseline to Month 12.
Change in Motor Evoked Potential (MEP) Amplitude
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).
Measured: Baseline to Month 12.
Change in Motor Evoked Potential (MEP) Latency
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).
Measured: Baseline to Month 12.
Change in Somatosensory Evoked Potential (SSEP) Amplitude
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).
Measured: Baseline to Month 12.
Change in Somatosensory Evoked Potential (SSEP) Latency
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).
Measured: Baseline to Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Guttmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981338
- Sponsor's protocol ID
- GNR-SCI-01
- Other IDs
- 2025-521877-14-00, 2025
- Acronym
- GNR-SCI-01
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06981338
- Acronym / sponsor ID
- GNR-SCI-01 / GNR-SCI-01
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institut GuttmannUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Allogeneic WJ-MSCs + tSCS-Assisted Neurorehabilitation | Experimental | Combination Product: Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- Severe comorbidities (e.g., cardiovascular instability, active infections)
- Individuals requiring mechanical ventilation
- Contraindications for tSCS (e.g., implanted devices)
- Pregnancy or breastfeeding
- Neurodegenerative diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)Also: Transcutaneous spinal cord stimulation (tSCS)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. | Combination product | Allogeneic WJ-MSCs + tSCS-Assisted Neurorehabilitation |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI
Time frame: Baseline through Month 12 post-treatment
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).
Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy
Time frame: From baseline to week 18.
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 (%).
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs) in people with Spinal Cord Injuries (SCI) and Spinal Cord Injury, run by Institut Guttmann at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Vidal Samsó, MD, PhD ((+34)934977700, jvidal@guttmann.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI (time frame: Baseline through Month 12 post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.