Trial intelligence / Profile preview

ACESO: Allogeneic hMSCs in Diabetic Endothelial Dysfunction

NCT02886884Phase 2

Key facts

Status: Completed
Start: Oct 2017
Primary completion: Aug 2019
Countries: 1
Modality: Stem Cell Therapies

Drugs: MSV alogénicas
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 2, randomised, double-blind trial of MSV alogénicas in type 2 diabetes mellitus (T2DM) (4 arms). Primary endpoint: Treatment Emergent Serious Adverse Events at 1 month. Started Oct 2017; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Pilot 20M
20 million allogeneic hMSCs (Pilot Phase)
Pilot 100M
100 million allogeneic hMSCs (Pilot Phase)
Randomized 20M
20 million allogeneic hMSCs (Randomized Phase)
Randomized 100M
100 million allogeneic hMSCs (Randomized Phase)

Who it enrols

Adults aged 21-90 with Type 2 Diabetes and endothelial dysfunction (FMD < 7%), excluding those with severe kidney disease, heart failure, uncontrolled diabetes (A1C > 8.5%), or recent malignancies.

Endpoints

Primary

Treatment Emergent Serious Adverse Events1 month

Secondary

Endothelial Progenitor Cell-Colony Forming UnitsDay 365
C-Reactive ProteinDay 365
Circulating Angiogenic Factor LevelsDay 365
Flow Mediated DiameterDay 365
Circulating Inflammatory Marker LevelsDay 365
Tumor Necrosis Factor AlphaDay 365

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