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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

March 1, 2026

Study Completion Date

December 31, 2028

Conditions
Spinal Cord Injuries (SCI)Spinal Cord InjuryTraumatic Spinal Cord InjuriesSpinal Cord Disease
Interventions
COMBINATION_PRODUCT

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.

Trial Locations (1)

08916

Institut Guttmann: Hospital de Neurorehabilitació, Badalona

All Listed Sponsors
lead

Institut Guttmann

OTHER

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 | Biotech Hunter | Biotech Hunter