Spinal Cord Injury Cervical Clinical Trial
Official title:
A Phase I/II, Randomized, Double-blind, Placebo-controlled, Parallel, 2-arms Clinical Trial to Assess the Safety and Efficacy of Intrathecal Administration of WJ-MSC in Chronic Traumatic Cervical Incomplete Spinal Cord Injury
Verified date | January 2024 |
Source | Banc de Sang i Teixits |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 20, 2024 |
Est. primary completion date | January 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Single spinal cord injury lesion caused by trauma 2. Affected cord segments between C1 and T1, confirmed by magnetic resonance 3. Incomplete lesion (ASIA B, C or D) 4. Chronic disease state (between 1 and 5 years after the injury) 5. Patients from 18 to 70 years of age, both sexes 6. Life expectancy > 2 years 7. Residence near the center during study participation and confidence that the patient will attend the follow-up visits 8. Given informed consent in writing 9. Patient is able to understand the study and its procedures Exclusion Criteria: 1. Mechanic ventilation 2. Penetrating trauma affecting the spinal cord 3. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding 4. Planned spinal surgery within subsequent 12 month after entering the trial 5. Neurodegenerative diseases 6. Significant abnormal laboratory tests that contraindicates patient's participation in the study 7. Neoplasia within the previous 5 years, or without complete remission 8. Patient with communication difficulties 9. Simultaneous participation in another clinical trial or treated with an investigational medicinal product the previous 30 days, that could interfere in the results of the study 10. Previous treatment with and advanced Therapy Medicinal Product (cell therapy) 11. Contraindication for lumbar punction 12. Contraindication or inability to follow a rehabilitation program 13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria 14. The patient does not accept to be followed-up for a period that could exceed the clinical trial length |
Country | Name | City | State |
---|---|---|---|
Spain | Complexo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | |
Spain | Hospital de Neurorehabilitació Institut Guttmann | Badalona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Banc de Sang i Teixits | Academic Research Organization (ARO) - VHIR, Complexo Hospitalario Universitario de A Coruña, Institut Guttmann |
Spain,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events | Adverse events | At 12 month follow-up | |
Secondary | 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 | |
Secondary | Motor evoked potentials | Changes in motor evoked potentials score with respect to baseline value. Higher scores mean a better outcome | At 6 and 12 month follow-up | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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