NCT04776239

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD)

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Joshua M Hare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.

Conditions

• Diabetes Mellitus
• Ischemic Heart Disease

Interventions

Type	Name	Description
DRUG	100 million Allogeneic Mesenchymal Human Stem Cells	1 single intravenous infusion
OTHER	Placebo	Placebo delivered via peripheral intravenous infusion

Timeline

• Start date: 2021-08-16
• Primary completion: 2025-03-30
• Completion: 2025-08-26
• First posted: 2021-03-01
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study