Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
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
Lead sponsor: Institut Guttmann
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI
timeFrame: Baseline through Month 12 post-treatment
measure: Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy
timeFrame: From baseline to week 18.
Secondary outcomes:
measure: Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Motor Score
timeFrame: Baseline to Month 12
measure: Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Light Touch Sensory Score
timeFrame: Baseline to Month 12.
measure: Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Pinprick Sensory Score
timeFrame: Baseline to Month 12.
measure: Change in Autonomic Control
timeFrame: Baseline to Month 12.
measure: Change in Motor Evoked Potential (MEP) Amplitude
timeFrame: Baseline to Month 12.
measure: Change in Motor Evoked Potential (MEP) Latency
timeFrame: Baseline to Month 12.
measure: Change in Somatosensory Evoked Potential (SSEP) Amplitude
timeFrame: Baseline to Month 12.
measure: Change in Somatosensory Evoked Potential (SSEP) Latency
timeFrame: Baseline to Month 12.
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Institut Guttmann: Hospital de Neurorehabilitació
state: Barcelona, Catalonia
Study officials:
References: