Cronic traumatic spinal cord injury MedDRA version: 20.1 Level: PT Classification code 10041554 Term: Spinal cord injury cervical System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: XCEL-UMC-BETA
Pharmaceutical Form: Infusion
INN or Proposed INN: ex vivo cultured human mesenchymal stem cells from Wharton jelly
Current Sponsor code: XCEL-UMC-BETA
Other descriptive na
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 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 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
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 (*) Allowed anticonceptive methods are: hormones, intrauterine dispositive, barrier methods, voluntarily sterilization or menopause >1year duration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Evaluate the efficacy of the intrathecal infusion of XCEL-UMC-BETA, by: - ASIA punctuation - Electrophysiology tests (motor and somatosensory evoked potentials. H and F waves) - Electrical pain threshold perception - Handgrip Strength by dynamometer - Walk test WISCIII - Numerical scale for neuropathic pain assessment - Modified Ashworth scale for spasticity - SCIM III scale for functionality - Quality of life questionnaire (WHOQOL-BREF) - Psychological examination (IBP, HAD) - Social work survey (CIQ-IG) - AntiHLA antibodies in cerebrospinal fluid (CSF) - Detection of donor cells in CSF;Main Objective: To assess the safety of intratecal infusion of XCEL-UMC-BETA;Primary end point(s): Safety will be assessed by physical examination, vital signs, laboratory data, and adverse events;Timepoint(s) of evaluation of this end point: At 12 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes from baseline in ASIA score at 1, 3, 4, 6 and 12 m, compared with placebo - Changes from baseline in electrophysiological tests at 6 and 12 m, compared with placebo -Changes with respect to the baseline in the threshold of perception of the electrical stimulus and of perception of pain by electrical current (in 7 levels: 1 level above, and -1, -2, -3, -4, -5 and -6 for below the lesion) at 3, 6, and 12 m, compared with placebo. - Changes from baseline in grasping, pressing and pinching strength by dynamometer at 6 and 12 m, compared with placebo. - Changes from baseline in the WISCIII Walk test at 6 and 12 m, compared with placebo. - Changes from baseline in the numerical scale for neuropathic pain at 6 and 12 m, compared with placebo. -Changes from baseline in the modified Ashworth Scale for spasticity at 6 and 12 m, compared with placebo. -Changes from baseline in the SCIM III scale at 6 and 12 m, compared with placebo. -Changes from baseline in the WHOQOL-BREF questionnaire at 6 and 12 m, compared with placebo. -Changes from baseline in the psychological examination at 12 m, compared with placebo. -Changes from baseline in the social work survey at 12 m, compared with placebo. - Presence or absence of ab-antiHLA in CSF after infusion of WJ-MSC (1 and 4 months). - The detection of donor cells in CSF will be assessed by detecting the presence or absence of donor cells (product infused) in the recipient CSF at 7 days after each infusion of WJ-MSC.;Timepoint(s) of evaluation of this end point: At 7 days and at 1, 3, 4, 6 and 12 months follow-up. | — |
Countries
Spain
Contacts
Public ContactSponsor
Banc de Sang i Teixits
Outcome results
None listed