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

Korábbi kezelés

• Have history of prior myocardial Infarction and revascularization.
• Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
• Be pregnant, nursing, or of childbearing potential and not on contraceptive medications. (May participate if on 2 forms of contraceptives).

Más betegség

• 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.
• 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.
• Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up.

Laborértékek

• 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 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 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions.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 serum positive for HIV, hepatitis B surface antigen (sAg), or viremic hepatitis C.

Életkor

• Be younger than 18 years of age.

Egyéb

• Coronary lesions with restenosis or heavy calcification.

• 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.