This study is to compare the safety and efficacy of UCMSCs and BMMSCs administered intravenously in patients to evaluate cytokine suppression in patients with chronic inflammation. Cells administered via intravenous infusion (IV) and will be tested in 37 patients in two phases (Pilot and Randomized).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
ISCI / University of Miami Miller School of Medicine
Miami, Florida, United States
Number of Treatment-Emergent Serious Adverse Events (TE-SAEs)
Number of treatment-emergent serious adverse events (SAE) (at one-month post infusion), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities, determined per the Investigator's judgment.
Time frame: one month post infusion
Cytokine Levels
Cytokine levels including the following panel of inflammatory and angiogenic markers: Interleukin-1 (IL-1), Interleukin-6 (IL-6), Tumor Necrosis Factor alpha (TNFα), and Vascular Endothelial Growth Factor (VEGF), \& Stromal Cell Derived Factor (SDF-1a) levels from serum/plasma samples all measured in pg/mL.
Time frame: at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6
hsCRP Levels
values at baseline and follow up for the following inflammatory marker: Serum High sensitivity C-Reactive Protein (hsCRP) in mg/L.
Time frame: at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6
Stem Cell Factor (SCF) Levels
SCF levels from serum/plasma samples measured in units of mg/mL
Time frame: at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6
Endothelial Progenitor Cell-Colony Forming Units (EPC-CFUs)
Endothelial function will be reported as the change in Endothelial Progenitor Cell Colony Forming Unit (EPC-CFU) assessed via blood sample assay
Time frame: at Baseline, and at 3 months
Flow Mediated Diameter Percentage (FMD%)
FMD% will be assessed using brachial artery ultrasound
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: at Baseline and at Month 3