Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Myocardial Ischemia
- Sponsor
- Centro Cardiologico Monzino
- Enrollment
- 12
- Locations
- 3
- Primary Endpoint
- Safety
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to evaluate whether endocavitary intramyocardial injection of autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events, with follow-up assessments extending up to 1 year after enrolment.
Detailed Description
This will be a Phase I study investigating the safety and preliminary efficacy of endocavitary injection of bone-marrow-derived CD133+ cells in 15 patients with ischemic heart failure (IHF) not eligible for conventional revascularization. Patients eligible will undergo bone-marrow aspiration. On the day following bone-marrow aspiration patients will undergo fluoroscopy-based endocavitary intramyocardial injections of the target areas previously identified by gated-SPECT/CMR. CD133+ cells suspended in physiological saline supplemented with 5% human albumin solution will be injected into the myocardium via the endocardial route. After discharge, efficacy follow-up will last 6-months safety follow-up (FU) will be extended up to 1 year.
Investigators
Giulio Pompilio
MD PhD
Centro Cardiologico Monzino
Eligibility Criteria
Inclusion Criteria
- •Ischemic heart failure not amenable to any type of revascularization procedure (percutaneous or surgical) as determined by one interventional cardiologist and one cardiovascular surgeon,
- •Canadian Cardiovascular Society Angina functional class III to IV angina and/or symptoms of heart failure (NYHA score IIb to IV) under state-of-the-art maximal medical therapy,
- •Left Ventricular Ejection Fraction between 20% and 45%,
- •Peak V02 ≤ 21 mL/Kg/min,
- •Presence of a reversible perfusion defect ≥ 10% of the left ventricular myocardium (at least 2 segments over 20) as determined by gated-SPECT, 6.18 years ≤ Age ≤ 75 years,
- •7.Hemodynamic stability, 8.Ability to accomplish a cardiopulmonary exercise testing, 9.Are not pregnant and do not plan to become pregnant during the study. Females with childbearing potential must provide a negative pregnancy test within 1-7 days before intervention and must be using oral or injectable contraception (non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start), 10.A signed consent form that has been approved by the institutional review board.
Exclusion Criteria
- •A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the past 3 months,
- •Presence of a documented unstable angina,
- •Left ventricular thrombus, as documented by echocardiography,
- •Evidence of a life-threatening arrhythmia,
- •Presence of any severe mitral valve disease requiring valve replacement or reconstruction,
- •Presence of a mechanical aortic valve,
- •Presence of stenosis of the aortic valve, graded as ≥+2 equivalent to an orifice area of 1,5 cm2 or less,
- •Presence of moderate to severe insufficiency of the aortic valve,
- •A left ventricular wall thickness of \<8 mm at the target site for cell injection, as assessed by 2-D echocardiography and/or cardiac MRI,
- •Have a known, serious radiographic contrast allergy,
Outcomes
Primary Outcomes
Safety
Time Frame: 1 year
The primary objective of this study will be to evaluate whether endocavitary intramyocardial injection of autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events, with follow-up assessments extending up to 1 year after enrolment.
Secondary Outcomes
- Efficacy(6 months)