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.
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
Severe comorbidities (e.g., cardiovascular instability, active infections)
Individuals requiring mechanical ventilation
Contraindications for tSCS (e.g., implanted devices)
Pregnancy or breastfeeding
Single group
Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs)
Combination productThis 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.
Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI
Safety assessment evaluating: 1. Neurological worsening (≥1-grade decline on the American Spinal Injury Association (ASIA) Impairment Scale \[AIS\], grades A-E, where higher grades indicate better function). 2. Cerebrospinal fluid (CSF) abnormalities (e.g., pleocytosis, elevated protein). 3. Procedure-related complications (e.g., post-lumbar puncture headache, infection). Unit of Measure: Composite binary outcome (presence/absence of any TEAE).
Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy
Feasibility assessment measuring adherence to: 1. Scheduled intrathecal WJ-MSC administrations (3 doses at 6-week intervals). 2. Concomitant tSCS-assisted neurorehabilitation sessions (18 weeks). Unit of Measure: Percentage of completed interventions vs. planned (%).
Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Motor Score
Change in motor function measured by the American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Motor Score, which evaluates voluntary muscle strength across 10 key muscle groups (0-5 points per muscle, total range 0-100). Higher scores indicate better motor function. Unit of Measure: Points on American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Motor Scale.
Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Light Touch Sensory Score
Change in light touch sensation measured by the American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Light Touch Sensory Score (0-112 points, tested across 28 dermatomes). Higher scores indicate better sensory function. Unit of Measure: Points on American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Light Touch Scale.
Change in American Spinal Injury Association (ASIA) Impairment Scale [AIS] Pinprick Sensory Score
Change in pinprick sensation measured by the American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Pinprick Sensory Score (0-112 points, tested across 28 dermatomes). Higher scores indicate better sensory function. Unit of Measure: Points on American Spinal Injury Association (ASIA) Impairment Scale \[AIS\] Pinprick Scale.
Change in Autonomic Control
Change in autonomic function (e.g., bladder, bowel, cardiovascular regulation) assessed using the International Standards to document Autonomic Function after Spinal Cord Injury (ISAFSCI). Scores range from 0 (no function) to 2 (normal function) per domain. Higher scores indicate better autonomic control. Unit of Measure: Autonomic Function after Spinal Cord Injury (ISAFSCI) composite score.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
