Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction

Azienda Unita Sanitaria Locale di Piacenza50 enrolled

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

Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mortality

Mortality and Morbidity

Left ventricular function

Secondary Outcomes

Left ventricular remodeling

Heart rate variability

Baroreflex sensitivity

Stress induced myocardial ischemia

Cell dose response

Central Contacts

Massimo Piepoli, MD, PhD

CONTACT

+390 523 303217 m.piepoli@ausl.pc.it

Daniele Vallisa, MD