Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction
Overview
We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy. After standard therapy for acute MI, 10 patients were transplanted with autologous mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute MI were treated by standard therapy alone. After
Full Title of Study: “Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
Detailed Description
Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).
Interventions
- Procedure: cell therapy, bone marrow derived stem cell
Clinical Trial Outcome Measures
Primary Measures
- Mortality
- Mortality and Morbidity
- Left ventricular function
Secondary Measures
- Left ventricular remodeling
- Heart rate variability
- Baroreflex sensitivity
- Stress induced myocardial ischemia
- Cell dose response
Participating in This Clinical Trial
Inclusion Criteria
- Recent acute transmural anterior myocardial infarction, (in agreement with WHO) – single left anterior descending coronary artery disease – <72 hour from the origin of symptoms – successful primary angioplasty of the culprit lesion Exclusion Criteria:
- screening >72 hours after infarction, – cardiac shock, severe comorbidity, alcohol or drug dependency – severe comorbidity (DM,renal or liver insufficiency) – potential child bearing woman – inability to provide informed consent
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Azienda Unità Sanitaria Locale di Piacenza
- Overall Official(s)
- Massimo Piepoli, MD, PhD, Principal Investigator, G. da Saliceto Hospital, Regional Health Authority
- Overall Contact(s)
- Massimo Piepoli, MD, PhD, +390 523 303217, m.piepoli@ausl.pc.it
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