Traumatic spinal cord injury
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Fundacio Institut Guttmann
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed