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
NCT ID: NCT06981338
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2025-09-01
2028-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
* 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.
TREATMENT
NONE
Study Groups
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Allogeneic WJ-MSCs + tSCS-Assisted Neurorehabilitation
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.
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 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.
Interventions
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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 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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
70 Years
ALL
No
Sponsors
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Institut Guttmann
OTHER
Responsible Party
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Locations
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Institut Guttmann: Hospital de Neurorehabilitació
Badalona, Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-521877-14-00
Identifier Type: CTIS
Identifier Source: secondary_id
GNR-SCI-01
Identifier Type: -
Identifier Source: org_study_id
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