ALLOGENEIC VIABLE WHARTON'S JELLY-DERIVED MESENCHYMAL STEM CELLS, EX-VIVO EXPANDED for Traumatic spinal cord injury

Inclusion criteria

• {"criterion_text":"-•Single spinal cord injury of traumatic aetiology, AIS grade A-C.\n-•Confirmed diagnosis of spinal cord injury at cervical or thoracic levels (C1–T12), based on clinical evaluation and previous medical imaging records.\n-•Duration of spinal cord injury greater than 1 year post-injury.\n-•Age range: 18-70 years.\n-•Life expectancy greater than 2 years.\n-•Ability to attend follow-up visits and participate in study procedures.\n-•Written informed consent.\n-•Adequate cognitive capacities in order to understand the nature of the study and provide consent.\n-•Willingness to comply with all therapeutic protocols and study procedures."}

Exclusion criteria

• {"criterion_text":"-•Severe comorbidities that, based on the criteria of the investigator, prevent the participant from participating in the study.\n-•Difficulties in communicating with the evaluators (language barriers, aphasia).\n-•Simultaneous participation in other clinical trials or treatment with other investigational products within 30 days prior to inclusion in the study, which may interfere with the study results.\n-•Intrathecal medication or immunosuppressive drugs in the last 60 days.\n-•Spinal cord injury with injury affecting multiple levels.\n-•Contraindications for lumbar puncture.\n-•Planned spinal surgery within 24 months after enrolment in the trial.\n-•Injury length exceeding 3 spinal cord segments, as determined by magnetic resonance imaging.\n-•Contraindications or inability to follow a rehabilitation programme.\n-•Other pathologies or circumstances which might compromise the individual's participation in the study based on medical criteria.\n-•Known allergic reactions to components present in stem cell preparations.\n-•Individuals receiving mechanical ventilation\n-•Contraindications for tSCS ( for instance, implanted devices that may interfere).\n-•Pregnant or breastfeeding women.\n-•Women with the potential to become pregnant who are not using a highly effective method of contraception, being considered ‘highly effective’ those that can achieve a failure rate of less than 1% per year when used consistently and correctly (*).(*)\tThe effective contraceptive methods considered in the protocol are hormonal methods, intrauterine devices (IUDs), barrier methods, voluntary sterilisation, or the participant having been in menopause for more than one year.\n-•Neurodegenerative diseases.\n-•Significant haematological and biochemical abnormalities that contraindicate participation in the study.\n-•Neoplastic disease detected in the last five years or without complete remission.\n-•Positive serology for HIV, HBV, HCV and/or syphilis."}

Primary endpoints

• {"endpoint_text":"-The safety assessment will take into account adverse events (AEs), physical examination, vital signs, and laboratory data. AEs of special interest will be specifically identified. AEs will be coded using MedDRA™. All AEs will be summarized with the number and percentage of patients with an AE, as well as the number and incidence of AEs by MedDRA™. Serious AEs (SSAs) will be highlighted and listed. Safety will be assessed using descriptive statistics in the safety population.","definition_or_measurement_approach":"Safety assessment based on adverse events monitoring, physical examination, vital signs and laboratory data; AEs coded using MedDRA™; summaries with number and percentage of patients with AEs and incidence by MedDRA™; serious AEs listed; safety analysed using descriptive statistics in the safety population."}

Secondary endpoints

• {"endpoint_text":"-Continuous variables assessed repeatedly over time will be analysed using mixed models for repeated measurements (longitudinal Mixed Model for Repeated Measurements (MMRM)), which will include time as a random factor, treatment as a fixed factor, and the interaction between time and treatment. The presence or absence of anti-HLA antibodies in CSF after the first and third infusions of WJ-MSC ( weeks 1 and 9) will be estimated using a logistic regression model.","definition_or_measurement_approach":"Statistical analysis: repeated continuous variables analysed using MMRM including time (random), treatment (fixed) and time*treatment interaction; presence/absence of anti-HLA antibodies in CSF after first and third infusions (weeks 1 and 9) estimated with logistic regression."}

Spain

Earliest CTIS Part Ii Submission Date

09-01-2026

Latest Decision Or Authorization Date

28-01-2026

Processing Time Days

19

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Fundacio Institut Guttmann

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca","duties_or_roles":"1,12,5,8","organisation_type":"Laboratory/Research/Testing facility"}