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Mesenchymal Stem Cells
BMMSCs for Metabolic Syndrome (CERES Trial)
Phase 1 & 2
Waitlist Available
Led By Joshua M Hare, MD
Research Sponsored by Joshua M Hare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at week 2, at month 1, at month 3, and at month 6
Awards & highlights
CERES Trial Summary
This trial will compare the safety and effectiveness of two types of cells, UCMSCs and BMMSCs, given through IV infusion to treat chronic inflammation. 37 patients will be tested in two phases.
Eligible Conditions
- Endothelial Dysfunction
- Metabolic Syndrome
- Chronic Inflammation
CERES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month post infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month post infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Treatment-Emergent Serious Adverse Events (TE-SAEs)
Secondary outcome measures
Cytokine
Endothelial Progenitor Cell-Colony Forming Units (EPC-CFUs)
Flow Mediated Diameter Percentage (FMD%)
+2 moreCERES Trial Design
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Pilot Phase: Group 4 (BMMSCs -100 million)Experimental Treatment1 Intervention
Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
Group II: Pilot Phase: Group 3 (UCMSCs - 100 million)Experimental Treatment1 Intervention
Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
Group III: Pilot Phase: Group 2 (BMMSCs - 20 million)Experimental Treatment1 Intervention
Three (3) subjects will be treated with a single IV administration of 2 x 10^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
Group IV: Pilot Phase: Group 1 (UCMSCs - 20 million)Experimental Treatment1 Intervention
Three (3) subjects will be treated with a single administration of 2 x 10^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
Group V: Group B (BMMSCs - 100 million)Experimental Treatment1 Intervention
Participants randomized to receive a single administration of 1 x 10^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
Group VI: Group A (UCMSCs - 100 million)Experimental Treatment1 Intervention
Participants randomized to receive a single administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
Group VII: Group C (Placebo)Placebo Group1 Intervention
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Find a Location
Who is running the clinical trial?
The Marcus FoundationOTHER
15 Previous Clinical Trials
1,486 Total Patients Enrolled
Joshua M HareLead Sponsor
15 Previous Clinical Trials
395 Total Patients Enrolled
Joshua M Hare, MDPrincipal InvestigatorISCI / University of Miami Miller School of Medicine
9 Previous Clinical Trials
245 Total Patients Enrolled
Frequently Asked Questions
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