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

NCT04776239 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 202008741R01HL134558-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endothelial dysfunction; Diabetes; Stem cells

Outcome Measures

Primary Outcomes (2)

• Brachial Artery Flow Mediated Diameter Percentage (FMD%)

  FMD% is measured via brachial artery ultrasound. The unit of measure is percent.

  Baseline, Week 2, Month 1, Month 3, and Month 6

• EPC-CFU Counts

  Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well.

  Baseline, Week 2, Month 1, Month 3, and Month 6

Secondary Outcomes (11)

• Fractional Flow Reserve (FFR)

  Baseline, Month 6

• Coronary Flow Reserve (CFR)

  Baseline, Month 6

• Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)

  Baseline, Week 2, Month 1, Month 3, and Month 6

• Seattle Angina Questionnaire (SAQ) Quality of Life (QL)

  Baseline, Week 2, Month 1, Month 3, and Month 6

• Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)

  1 month post infusion

Study Arms (2)

Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group

EXPERIMENTAL

Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).

Drug: 100 million Allogeneic Mesenchymal Human Stem Cells

Group B: Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.

Other: Placebo

Interventions

100 million Allogeneic Mesenchymal Human Stem Cells DRUG

1 single intravenous infusion

Also known as: allo-human Mesenchymal Stem Cells (hMSCs), stem cells

Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group

Placebo OTHER

Placebo delivered via peripheral intravenous infusion

Group B: Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥ 18 years of age (males and females).
• Provide written informed consent.
• Have a diagnosis of symptomatic ischemic heart disease (IHD) and an indication for standard-of-care coronary angiography.
• Have Diabetes Mellitus (DM) type 2 documented by glycated hemoglobin (HbA1C) \> 7%, or on medical therapy for diabetes.

You may not qualify if:

• Be younger than 18 years of age.
• Have history of prior myocardial Infarction and revascularization.
• Have a baseline glomerular filtration rate (GFR) \<30 ml/min 1.73m2 estimated using the Modification of Diet for Renal Disease (MDRD) formula.
• Have poorly controlled blood glucose levels with hemoglobin A1C \> 8.5% in the previous 3 months.
• Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment.
• Have an indication for standard-of-care surgical (including valve surgery, placement of left-ventricular assist device) or percutaneous intervention for the treatment of valvular heart disease (including valvuloplasty).
• Have known hypersensitivity or contraindication to aspirin; both heparin and bivalirudin; all available P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor); or any zotarolimus, cobalt, chromium, nickel, tungsten, acrylic, or fluoropolymers; or hypersensitivity to contrast media that cannot be adequately premedicated.
• Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/microliter (uL) or platelet values \< 100,000/uL without another explanation (per investigator discretion).
• Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal.
• Have a bleeding diathesis or coagulopathy (INR \> 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions.
• Be an organ transplant recipient or have a history of organ or cell transplant rejection.
• Have a clinical history of malignancy within the past 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively-treated basal cell or squamous cell carcinoma, or cervical carcinoma.
• Have a condition that limits lifespan to \< 1 year.
• Have a history of drug or alcohol abuse within the past 24 months.
• Be serum positive for HIV, hepatitis B surface antigen (sAg), or viremic hepatitis C.

Sponsors & Collaborators

• Joshua M Hare: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Links

• Description: Interdisciplinary Stem Cell Institute at the University of Miami Miller School website

MeSH Terms

Conditions

Diabetes Mellitus; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Joshua M. Hare, MD
• Organization: University of Miami, Miller School of Medicine - Interdisciplinary Stem Cell Institute (ISCI)

jhare@med.miami.edu

305-243-5579

Study Officials

• Nikolaos Spilias, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 1, 2021
• Study Start: August 16, 2021
• Primary Completion: March 30, 2025
• Study Completion: August 26, 2025
• Last Updated: June 16, 2026
• Results First Posted: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)