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

BST-SCI-02

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.

2021-10-13

2024-01-20

2024-01-20

Completed

Early phase I

18

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind, randomized, placebo-controlled, 2-arms, multicenter clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2024-01-24