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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521877-14-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic WJ-MSCs + tSCS-Assisted Neurorehabilitation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Wharton's jelly mesenchymal stem cells (WJ-MSCs) | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) in Chronic SCI | Safety assessment evaluating:
Unit of Measure: Composite binary outcome (presence/absence of any TEAE). | Baseline through Month 12 post-treatment |
| Protocol Adherence Rate for Combined WJ-MSCs and tSCS Therapy | Feasibility assessment measuring adherence to:
| From baseline to week 18. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joan Vidal Samsó, MD, PhD | Contact | (+34)934977700 | jvidal@guttmann.com | |
| Fernando Martins Braga, MD, MSc | Contact | (+34)934977700 | fmartins@guttmann.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Guttmann: Hospital de Neurorehabilitació | Badalona | Barcelona, Catalonia | 08916 | Spain |
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This single-arm, open-label pilot study combines intrathecal Wharton's jelly mesenchymal stem cells (3 doses of 30×10⁶±30% cells at 6week-intervals) with transcutaneous spinal cord stimulation (tSCS) in chronic SCI patients (AIS A-C, 1-5 years post-injury). The model evaluates:
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| Baseline to Month 12 |
| 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. | Baseline to Month 12. |
| 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. | Baseline to Month 12. |
| 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. | Baseline to Month 12. |
| Change in Motor Evoked Potential (MEP) Amplitude | Change in corticospinal tract integrity measured by Motor Evoked Potential (MEP) amplitude during transcranial magnetic stimulation. In the absence of pathological hyperexcitability, higher MEP amplitudes generally reflect better corticospinal tract integrity. Unit of Measure: Microvolts (µV). | Baseline to Month 12. |
| Change in Motor Evoked Potential (MEP) Latency | Change in corticospinal conduction speed measured by Motor Evoked Potential (MEP) latency during transcranial magnetic stimulation. Shorter latencies generally reflect faster, more efficient corticospinal tract conduction. Unit of Measure: Milliseconds (ms). | Baseline to Month 12. |
| Change in Somatosensory Evoked Potential (SSEP) Amplitude | Change in dorsal column-medial lemniscus pathway integrity measured by Somatosensory Evoked Potential (SSEP) amplitude during peripheral nerve stimulation. In the absence of pathological hyperexcitability, higher SSEP amplitudes generally reflect better somatosensory pathway integrity. Unit of Measure: Microvolts (µV). | Baseline to Month 12. |
| Change in Somatosensory Evoked Potential (SSEP) Latency | Change in somatosensory pathway conduction speed measured by Somatosensory Evoked Potential (SSEP) latency during peripheral nerve stimulation. Shorter latencies generally reflect faster, more efficient conduction along the dorsal column-medial lemniscus pathway. Unit of Measure: Milliseconds (ms). | Baseline to Month 12. |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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