PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy (The POSEIDON-DCM Study) (PoseidonDCM)
Non-ischemic Dilated Cardiomyopathy
About this trial
This is an interventional treatment trial for Non-ischemic Dilated Cardiomyopathy focused on measuring Non ischemic dilated cardiomyopathy, Dilated cardiomyopathy, Heart failure, Cardiac Stem Cell Transplantation, Stem Cells
Eligibility Criteria
Major Inclusion Criteria:
- Be ≥ 18 and < 95 years of age.
- Provide written informed consent.
- Diagnosis of nonischemic dilated cardiomyopathy.
- Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
- Been treated with appropriate maximal medical therapy for heart failure.
- Ejection fraction below 40% and either a left ventricular end diastolic diameter (LVEDD) > 5.9cm in male subjects, an LVEDD of > 5.6cm in female subjects or left ventricular end diastolic volume index > 125 mL/m2
- Be able to undergo an MRI or CT.
Major Exclusion Criteria:
- Baseline glomerular filtration rate equal or < 45 ml/min/1.73m2.
- Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of nonischemic dilated cardiomyopathy.
- Presence of a prosthetic aortic valve or heart constrictive device.
- Presence of a prosthetic mitral valve.
- Previous myocardial infarction (MI) as documented by a clinical history that will include an elevation of cardiac enzymes and/or ECG changes consistent with MI.
- Diagnosis of nonischemic dilated cardiomyopathy due to valvular dysfunction, mitral regurgitation, tachycardia, or myocarditis.
- Previous treatment for post-infarction left ventricular dysfunction including PCI and thrombolytic therapy.
- Documented presence of a known LV thrombus, aortic dissection, or aortic aneurysm.
- Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries.
- Documented presence of aortic stenosis (aortic stenosis graded as 1.5cm2 or less).
- Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
- Evidence of a life-threatening arrhythmia in the absence of a defibrillator (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete second or third degree heart block in the absence of a functioning pacemaker) or QTc interval > 550 ms on screening ECG.
- AICD firing in the past 30 days prior to the procedure
- Be eligible for or require coronary artery revascularization.
- Diabetic with poorly controlled blood glucose levels and/or evidence of proliferative retinopathy.
- Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values < 100,000/ul without another explanation.
- Have liver dysfunction, as evidenced by enzymes (ALT and AST) greater than three times the ULN.
- Have a coagulopathy condition = (INR > 1.3) not due to a reversible cause.
- Known, serious radiographic contrast allergy.
- Known allergies to penicillin or streptomycin.
- Organ transplant recipient.
- Have a history of organ or cell transplant rejection
- Clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
- Non-cardiac condition that limits lifespan to < 1 year.
- On chronic therapy with immunosuppressant medication.
- Serum positive for HIV, hepatitis BsAg, or viremic hepatitis C.
- Female patient who is pregnant, nursing, or of child-bearing potential and not using effective birth control.
- Have a history of drug or alcohol abuse within the past 24 months.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
Sites / Locations
- University of Miami School of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Autologous hMSCs
Allogeneic hMSCs
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.