Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut Guttmann | OTHER |
| Academic Research Organization (ARO) - VHIR | UNKNOWN |
| Complexo Hospitalario Universitario de A Coruña | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to either the active treatment (2 doses of intrathecal WJ-MSC 3 months apart) or to placebo (2 intrathecal infusions, 3 months apart). Thereafter, patients will be followed-up for 12 months for safety and efficacy assessment.
Double-blind, randomized, placebo-controlled, multicenter clinical trial that will include 18 patients affected with chronic traumatic incomplete cervical spinal cord injury who will be randomized 1:1, stratified by center, to one of the 2 treatment arms of the study: WJ-MSC / WJ-MSC (at a dose of 1E6 ± 30% live cells / Kg of weight) or Placebo / placebo. Medication will be administered intrathecally at day 1 and at 3 months. The main objective of the trial is to assess safety at a 12-month follow-up. Secondary objectives include the evaluation of efficacy through clinical response, electrophysiological changes, questionnaires of functionality and quality of life, as well as the presence of anti-HLA antibodies and donor cellularity in the cerebrospinal fluid.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WJ-MSC (XCEL-UMC-BETA) | Experimental | Pre-filled syringe with 4 ± 1 mL containing WJ-MSC in a balanced saline solution supplemented with human albumin. |
|
| Placebo | Placebo Comparator | Pre-filled syringe with 4 ± 1 mL containing a balanced saline solution supplemented with human albumin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WJ-MSC (XCEL-UMC-BETA) | Drug | Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Adverse events | At 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| American Spinal Injury Association (ASIA) impairment scale | Changes in ASIA score with respect to baseline value as detailed at https://asia-spinalinjury.org/international-standards-neurological-classification-sci-isncsci-worksheet/ | At 1, 3, 4, 6 and 12 month follow-up |
| Motor evoked potentials |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joan VIDAL, MD, PhD | Institut Guttmann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de NeurorehabilitaciĂł Institut Guttmann | Badalona | Barcelona | 08916 | Spain | ||
| Complexo Hospitalario Universitario A Coruña (CHUAC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32981857 | Background | Albu S, Kumru H, Coll R, Vives J, Valles M, Benito-Penalva J, Rodriguez L, Codinach M, Hernandez J, Navarro X, Vidal J. Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy. 2021 Feb;23(2):146-156. doi: 10.1016/j.jcyt.2020.08.008. Epub 2020 Sep 25. |
| Label | URL |
|---|---|
| Blood and tissue bank of Catalonia, cell producer and sponsor of the trial | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Double-blind, randomized, placebo-controlled, 2-arms, multicenter clinical trial
Not provided
Not provided
Active treatment and placebo will be released using the same syringe and blinded in a way that it is no possible to distinguish one to the other.
| Placebo | Drug | Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months |
|
Changes in motor evoked potentials score with respect to baseline value. Higher scores mean a better outcome |
| At 6 and 12 month follow-up |
| Somatosensory evoked potentials | Changes in somatosensory evoked potentials score with respect to baseline value. Higher scores mean a better outcome | At 6 and 12 month follow-up |
| Electrical pain threshold perception | Changes in electrical pain threshold perception score with respect to baseline. Lower scores mean a better outcome | At 6 and 12 month follow-up |
| Handgrip Strength | Will be assessed using a dynamometer. Changes in the score with respect to baseline values. Higher scores mean a better outcome | At 6 and 12 month follow-up |
| Walking index for spinal cord injury (WISCI II) | Changes in the walk test WISCIII score with respect to baseline value. The score ranges from 0 (most severe impairment) to 20 (least severe impairment) | At 6 and 12 month follow-up |
| Numerical scale for neuropathic pain assessment | Changes in the numerical scale for neuropathic pain score with respect to baseline value. Score ranges from 0 (no pain) to 10 (unbearable pain) | At 6 and 12 month follow-up |
| Modified Ashworth scale for spasticity | Changes in the modified Ashworth scale score with respect to baseline value. It is a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension, and includes a 1+ value. | At 6 and 12 month follow-up |
| Spinal Cord Independence Measure III (SCIM III) | Changes in the SCIM III scale score with respect to baseline value. Score ranges from 0 to 20 with higher scores meaning better outcome. | At 6 and 12 month follow-up |
| World Health Organization Quality of life questionnaire (WHOQOL-BREF) | Changes in the WHOQOL-BREF score with respect to baseline value. It contains contains 26 questions each punctuated from 1 to 5 and assesses the individual's overall perception of quality of life (1 to 5), overall perception of their health (1 to 5) and 4 domains of physical health, psychological, social relationships, environment (0-100 each domain). higher scores denote higher quality of life. | At 6 and 12 month follow-up |
| Psychological general well-being index (PGWBI) | Changes in the PGWBI score with respect to baseline value. Score ranges from 0 to 132, with higher scores meaning a better outcome. | At 12 month follow-up |
| Hospital Anxiety and Depression Scale (HADS) | Changes in the HADS score with respect to baseline value. This is a 14-item self-administered questionnaire containing 2 subscales (one for anxiety and one for depression), with a score range of each subscale from 0-21. Higher score indicates higher anxiety and depression. | At 12 month follow-up |
| Community Integration Questionaire (CIQ-IG) | Changes in the CIQ-IG score with respect to baseline value. Score ranges from 0 to 25, with higher scores meaning a better outcome. | At 12 month follow-up |
| AntiHLA antibodies in cerebrospinal fluid (CSF) | Presence or absence of antiHLA antibodies in the CSF after two WJ-MSC infusions | At 7 days and at 1 month follow-up after each infusion |
| Detection of donor cells in CSF | Short tandem repeat (STR) analysis to detect permanence of donor cellularity (WJ-MsC) in the CSF | At 7 days after each infusion |
| A Coruña |
| 15006 |
| Spain |
| Hospital specialized in spinal cord injury | View source |
| Hospital specialized in spinal cord injury | View source |
| D014947 | Wounds and Injuries |