Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults over 18 with type 2 diabetes and symptomatic ischemic heart disease needing coronary angiography. Participants must have an HbA1C > 7% or be on diabetes medication, but not pregnant, nursing, or without contraception if of childbearing potential. Exclusions include organ transplant recipients, certain infections like HIV/hepatitis, recent participation in other trials, severe kidney/liver/blood conditions, allergies to specific medications used in the study.Inclusion Criteria
I have type 2 diabetes with an HbA1C over 7% or I am on medication for it.
I have heart disease symptoms and need a heart vessel check.
I have heart disease symptoms and need a heart vessel check.
+4 more
Exclusion Criteria
You have low red blood cell, white blood cell, or platelet counts without a clear reason.
I am not pregnant, nursing, or if capable of becoming pregnant, I am on two forms of contraception.
You have a medical condition that is expected to shorten your life to less than one year.
+16 more
Participant Groups
The ACESO-IHD trial is testing whether injecting 100 million allogeneic Mesenchymal Human Stem Cells can repair blood vessel lining better than a placebo in diabetic patients with heart issues due to blocked arteries. The stem cells are thought to help fix bone marrow cells that aid healing.
2Treatment groups
Experimental Treatment
Group I: Group A: Allogeneic Mesenchymal Stem Cells (MSCs) GroupExperimental Treatment1 Intervention
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
Group II: Group 2: Placebo GroupExperimental Treatment1 Intervention
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
Joshua M HareLead Sponsor
University of MiamiLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator