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LMSCs for Metabolic Syndrome
NCT02587572Phase 2
Key facts
- Status
- Withdrawn
- Start
- Dec 2023
- Primary completion
- Dec 2023
- Sponsor
- Longeveron
- Modality
- Stem Cell Therapies
- Drugs
- laromestrocel
- Conditions
- metabolic syndrome
01
Overview
Phase 2, randomised, double-blind trial of laromestrocel in metabolic syndrome (4 arms), sponsored by Longeveron. Primary endpoint: Changes in endothelial function at 1 month. Planned start Dec 2023; status: withdrawn.
02
Design
4 arms- Study design
- RandomizedDouble-blind
LMSCs 10M
10 million LMSCs IV
LMSCs 20M
20 million LMSCs IV
LMSCs 100M
100 million LMSCs IV
Placebo
Placebo (Plasmalyte A + HSA) IV
03
Who it enrols
Patients aged 45-85 with endothelial dysfunction and metabolic syndrome (meeting at least 3 of 5 harmonized criteria). Excludes patients with diabetic retinopathy, severe hypertension (>180/110 mmHg), low oxygen saturation (<93%), or recent malignancy.
04
Endpoints
Primary
Changes in endothelial function
Secondary
Difference in rate of change in the metabolic syndrome
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