Chronic traumatic spinal cord injury MedDRA version: 18.1 Level: PT Classification code 10041558 Term: Spinal cord injury thoracic System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: células mesenq troncales adultas alogénicas de gelatina de Wharton del CU expandidas criopreservadas
Product Code: XCEL-UMC-BETA
Pharmaceutical Form: Solution for infusion in pre-filled
Sponsors
Banc de Sang i Teixits
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Single spinal cord injury lesion caused by trauma 2. Affected cord segments between T2 and T11, confirmed by magnetic resonance 3. Complete paraplegia (ASIA A) 4. Chronic disease state (between 12 months and 5 years after the injury) 5. Patients from 18 to 65 years of age, both sexes 6. Life expectancy > 2 years 7. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Mechanic ventilation 2. Lesion affecting multiple levels 3. Lesion length superior to 3 spinal cord segments, assessed by magnetic resonance 4. Penetrating trauma affecting the spinal cord 5. Positive serology to HIV, HBV, HCV and or syphilis 6. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding 7. Use of metal implants difficulting the MRI 8. Planned spinal surgery within subsequent 24 month after entering the trial 9. Intrathecal medication or immunossupresive drugs the previous 60 days. 10. Neurodegenerative diseases 11. Significant abnormal laboratory tests that contraindicates patient's participation in the study. 12. Neoplasia within the previous 5 years, or without complete remission 13. Patient with communication difficulties 14. Participation in another clinical trial or treated with an investigational medicinal product the previous 60 days 15. Contraindication for lumbar punction 16. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria 17. The patient does not accept to be followed-up for a period that could exceed the clinical trial length (*) Allowed anticonceptive methods are: hormones, intrauterine dispositive, barrier methods, voluntarily sterilization or menopause >1year duration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of XCEL-UMC-BETA infusion in the treatment of thoracic level complete traumatic chronic spinal cord injury, from 12 month to 5 years evolution.;Secondary Objective: - To assess efficacy of XCEL-UMC-BETA infusion in the treatment of thoracic level complete traumatic chronic spinal cord injury, from 12 month to 5 years evolution, by: a) ASIA assessment b) Electrophysiology tests (motor and somatosensory evoked potentials. H and F waves) c) Electrical pain threshold perception d) Urodynamic testing e) Anorectal manometry test - Clinical assessment of XCEL-UMC-BETA infusion in the treatment of thoracic level complete traumatic chronic spinal cord injury, from 12 month to 5 years evolution, by: a) Numerical scale for neuropathic pain assessment b) Modified Ashworth scale for spasticity c) SCIM III scale for functionality d) Quality of life questionnaire (EUROQOL-5D) e) Qualiveen questionnaire - Assessment of changes by magnetic resonance imaging;Primary end point(s): - Safety assessment through adverse events, physical exam, vital signs and laboratory data.;Timepoint(s) of evaluation of this end point: month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Efficacy will be assessed though changes in respect to basal parameters for each period: a) ASIA punctuation at 1, 3 and 6 months (1, 3, 6, 7, 9 and 12 months of the study) b) Electrophysiology tests (motor and somatosensory evoked potentials. H and F waves) at 1, 3 and 6 months (1, 3, 6, 7, 9 and 12 months of the study) c) Electrical pain threshold perception at 1, 3 and 6 months (1, 3, 6, 7, 9 and 12 months of the study) d) Urodynamic testing at 6 months (6 and 12 months of the trial) e) Anorectal manometry test at 6 months (6 and 12 months of the trial) - Assessment of clinical changes at 1, 3 and 6 months of each period (1, 3, 6, 7, 9 and 12 months of the study), in respect to basal parameters, for: a) Numerical scale for neuropathic pain assessment b) Modified Ashworth scale for spasticity c) SCIM III scale for functionality d) Quality of life questionnaire (EUROQOL-5D) e) Qualiveen questionnaire (at month 6 of each period) (6 and 12 months of the trial) - Changes by magnetic resonance imaging on the size and lesion characteristics at month 6 in respect to basal parameters, for each period (6 and 12 months of the trial);Timepoint(s) of evaluation of this end point: month 12 | — |
Countries
Spain
Contacts
Public ContactDirec Med División Terap Avanzadas
Banc de Sang i Teixits
Outcome results
None listed