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

Launched by INSTITUT GUTTMANN · May 12, 2025

Keywords

ClinConnect Summary

The Guttmann NeuroRecovery trial is a research study designed to explore a new treatment for people with chronic spinal cord injuries (SCI). Specifically, it will look at the safety and effectiveness of combining two therapies: injections of special stem cells derived from Wharton's jelly (a substance found in the umbilical cord) and a non-invasive technique called transcutaneous spinal cord stimulation (tSCS), which stimulates the spinal cord through the skin. The trial aims to see if this combination can help improve movement and sensation in individuals who have had a spinal cord injury for at least one year.

To participate, individuals aged 16 to 70 with a single traumatic spinal cord injury at the neck or upper back levels (classified as ASIA A-C) may be eligible. Participants will receive three injections of stem cells and take part in rehabilitation sessions over a 12-month period to monitor their safety and any potential improvements in their condition. It's important to note that the study is not yet recruiting participants, and those interested will have to meet certain health and safety criteria to qualify. This trial represents a promising effort to discover new ways to support recovery in those living with spinal cord injuries.

Gender

ALL

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