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

Phase 1

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT00437710
• Lead Sponsor: Azienda Unità Sanitaria Locale di Piacenza

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2005-07
• Status Verified: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Last Update Submitted: 2010-03-23
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mortality
Mortality and Morbidity
Left ventricular function

Secondary Outcome Measures

Name	Time	Method
Left ventricular remodeling
Heart rate variability
Baroreflex sensitivity
Stress induced myocardial ischemia
Cell dose response

Trial Locations

Locations (1)

G da Saliceto Hospital; 🇮🇹 Piacenza, Italy