A Phase 1/2 interventional study of WJ-MSC (XCEL-UMC-BETA) and Placebo in Spinal Cord Injury Cervical, sponsored by Banc de Sang i Teixits. Completed at 2 sites in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Banc de Sang i Teixits · Phase 1/2, Interventional, and Treatment
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 18 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Banc de Sang i Teixits is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pre-filled syringe with 4 ± 1 mL containing WJ-MSC in a balanced saline solution supplemented with human albumin.
Drug: WJ-MSC (XCEL-UMC-BETA)
Pre-filled syringe with 4 ± 1 mL containing a balanced saline solution supplemented with human albumin
Drug: Placebo
Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months
Also known as: Tested product
Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months
Incidence of adverse events
Adverse events
Time frame: At 12 month follow-up
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/
Time frame: At 1, 3, 4, 6 and 12 month follow-up
Motor evoked potentials
Changes in motor evoked potentials score with respect to baseline value. Higher scores mean a better outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: At 7 days after each infusion
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Banc de Sang i Teixits