Cell Therapy in Critical Limb Ischemia
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Critical Limb Ischemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Demographics, baseline and follow-up characteristics: descriptive statistics. Primary analysis: Descriptive statistics for the rate of patients with high grade AEs (grade 2 and more), related to the cell implantation will be computed in each arm, with its two-sided 95% CIs. Each dose arm will be com...
Demographics, baseline and follow-up characteristics: descriptive statistics. Primary analysis: Descriptive statistics for the rate of patients with high grade AEs (grade 2 and more), related to the cell implantation will be computed in each arm, with its two-sided 95% CIs. Each dose arm will be compared to the control arm by computing the absolute difference and the relative risk between the active dose arm and the control arm, together with their 95% two-sided CIs. The p-values for the comparisons of the difference between the observed absolute rate to 0 and of the relative risk to 1 will be computed, but it is not expected that the study will have sufficient power to detect a significant difference on either of the two statistics (absolute difference or relative risk). Primary efficacy analysis: The primary efficacy criterion (TcPO2) will be compared between each dose group versus the control group to test for a superiority of MSC over control. The tested hypotheses are: Null hypothesis: mean (MSC dose i) ? mean (Control) Alternative hypothesis: mean (MSC dose i) > mean (Control) A mixed - model for repeated measures will be used to model the evolution of TcPO2 over time. The significance of the time by treatment interaction will be used to test the two hypotheses. Model adjusted means (LS means) and their differences between treatment arms will be computed at each timepoint. The LS-Means for change from baseline to 180 days will be used as the primary efficacy endpoint. Other efficacy analyses: the same analysis model (mixed - model for repeated measures) will be used for all the other continuous efficacy endpoints.
Tracking Information
- NCT #
- NCT03994666
- Collaborators
- Not Provided
- Investigators
- Not Provided
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