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 (GNR-SCI-01)

Guttmann Institute

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Spinal Cord Injuries (SCI); Traumatic Spinal Cord Injuries; Spinal Cord Disease; Spinal Cord Injury

Treatments: Combination Product: Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)

Study type: Interventional

Funder types: Other

Identifiers

NCT06981338

2025-521877-14-00 (EU Trial (CTIS) Number)

GNR-SCI-01

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Allogeneic WJ-MSCs + tSCS-Assisted Neurorehabilitation

Experimental group

Description:

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.

Treatment:

Combination Product: Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)