Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression.
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 37
Summary
- Conditions
- Chronic Inflammation
- Endothelial Dysfunction
- Metabolic Syndrome
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 95 years
- Gender
- Both males and females
Description
In this Study, cells administered via intravenous infusion (IV) will be tested in 37 patients in two phases (Pilot and Randomized): The pilot phase will consist of 12 subjects and the randomized phase will consist of 25 subjects. Subjects in each pilot phase group (Group 1, 2, 3 and 4) will not be t...
In this Study, cells administered via intravenous infusion (IV) will be tested in 37 patients in two phases (Pilot and Randomized): The pilot phase will consist of 12 subjects and the randomized phase will consist of 25 subjects. Subjects in each pilot phase group (Group 1, 2, 3 and 4) will not be treated less than 5 days apart and will each undergo full evaluation post infusion to demonstrate there is no evidence of treatment emergent SAE's prior to proceeding with the treatment of further subjects. For subjects randomized to Group 3, 4, C and D (BMMSCs); the cells will be derived from a sample of the subject's bone marrow (obtained by iliac crest aspiration) approximately 4-6 weeks prior to infusion. Duration of Study Participation will be 12 months (Follow-up will be at 2 weeks, 1 Month, 3, 6, and 12 months.)
Tracking Information
- NCT #
- NCT03059355
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Joshua M Hare, MD ISCI / University of Miami Miller School of Medicine
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