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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

NCT06981338 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-25

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries (SCI)
  • Spinal Cord Injury
  • Traumatic Spinal Cord Injuries
  • Spinal 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.

Sponsors & Collaborators

  • Institut Guttmann

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-03-01
Completion
2028-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06981338 on ClinicalTrials.gov