Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic S… (NCT04776239) | Clinical Trial Compass
CompletedPhase 1/2
Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD)
United States26 participantsStarted 2021-08-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Be younger than 18 years of age.
. Have history of prior myocardial Infarction and revascularization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used donor stem cells — not the patient's own — to treat endothelial dysfunction in people with both diabetes and ischemic heart disease. Given that it's a Phase 1/2 study, what do we actually know so far about whether this approach appeared safe, and is there any published data from ACESO-IHD I could review with you?
2The trial measured something called brachial artery flow-mediated dilation and circulating progenitor cell counts as its main outcomes — do those markers translate into real-world improvements in heart symptoms or long-term outcomes for someone in my situation, or are they still considered early research signals?
3Since this trial is completed, would the results change anything about my current treatment plan, or is the standard-of-care approach for ischemic heart disease in a diabetic patient still the more evidence-backed path for me right now?
4Because allogeneic stem cells come from a donor rather than the patient, is there a meaningful risk of immune reaction or rejection, and how would my doctors monitor and manage that if I were ever to pursue a similar therapy?
5Are there any follow-on trials or expanded-access programs building on this completed study that my care team thinks would be worth exploring given my specific combination of diabetes and ischemic heart disease?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).