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Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial

NCT02587572 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-02-16

No results posted yet for this study

Summary

This is a phase 2b, randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic syndrome and to assess the effects of LMSCs on endothelial function using several different doses.

Conditions

  • Metabolic Disease
  • Endothelial Dysfunction

Interventions

BIOLOGICAL

Peripheral Intravenous (IV) infusion of LMSCs

Peripheral Intravenous (IV) infusion of LMSCs

Sponsors & Collaborators

Principal Investigators

  • Anthony Oliva, PhD · Longeveron Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02587572 on ClinicalTrials.gov