A Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Efficacy of Allogeneic Human Mesenchymal Stem Cells in Patients With Metabolic Syndrome.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Metabolic Disease
- Sponsor
- Longeveron Inc.
- Primary Endpoint
- Endothelial function: Changes in endothelial function as assessed by the following:
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
This is a 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. Following a successful run-in phase, a total of forty (40) subjects will be randomized (1:1:1:1) to receive one of three different doses of LMSCs or placebo. After randomization, baseline imaging, testing and study product infusion, subjects will be followed up at 24 hours, month 1, month 3, month 6, month 9 and month 12 post study product infusion. All endpoints will be assessed at the 3, 6 and 12 month visits which will occur 90±30 days, 180±30 days, and 365±30 days respectively from the day of the study product infusion (Day 1). For the purposes of the endpoint analysis and safety evaluations, an "intent-to-treat" study population will be utilized.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Each subject must provide written informed consent.
- •Each subject must be ≥45 and ≤ 85 years of age at the time of signing the Informed Consent Form.
- •Each subject must have endothelial dysfunction.
- •At the time of enrollment, each subject must meet at least 3 out of the 5 criteria under the harmonized definition of the metabolic syndrome, consisting of the following
- •Hypertension.
- •Elevated triglycerides.
- •Reduced high-density lipoprotein (HDL) levels.
- •Elevated fasting glucose. --Central obesity.
Exclusion Criteria
- •Be unable and/or unwilling to perform any of the assessments required for endpoint analysis.
- •Have diabetic retinopathy.
- •Sitting or resting systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg at Screening.
- •Have a resting blood oxygen saturation of \<93% (measured by pulse oximetry).
- •Be hypersensitive to dimethyl sulfoxide (DMSO).
- •Have a history of alcohol or drug abuse within the past 24 months.
- •Have been diagnosed with malignancy within the past 5 years, with the exception of curatively-treated basal cell carcinoma, melanoma in situ or cervical carcinoma.
- •Be an organ transplant recipient.
- •Be actively listed (or expected to be listed) for transplant of any organ.
- •Have a condition that limits life expectancy to \< 1 year.
Outcomes
Primary Outcomes
Endothelial function: Changes in endothelial function as assessed by the following:
Time Frame: 1 month post infusion
Flow-mediated vasodilation (FMD). Endothelial progenitor cell (EPC) function.
Secondary Outcomes
- Difference in rate of change in the metabolic syndrome as defined by the following:(Baseline, 3 month, 6 month and 12 months.)