Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Institut Guttmann
Conditions:
Spinal Cord Injuries (SCI)
Spinal Cord Injury
Eligibility:
All Genders
16-70 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06981338
Start Date
September 1 2025
End Date
December 31 2028
Last Update
May 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Guttmann: Hospital de Neurorehabilitació
Badalona, Barcelona, Catalonia, Spain, 08916