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

Acute Myocardial Infarction Clinical Trial

— CARDIAC  

Official title:

Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00437710
• Other study ID #: 01/2007
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 20, 2007
• Last updated: March 23, 2010
• Start date: July 2005
• Est. completion date: February 2007

Study information

• Verified date: February 2007
• Source: Azienda Unità Sanitaria Locale di Piacenza
• Contact: Massimo Piepoli, MD, PhD
• Phone: +390 523 303217
• Email: m.piepoli[@]ausl.pc.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• cell therapy, bone marrow derived stem cell

Locations

Country	Name	City	State
Italy	G da Saliceto Hospital	Piacenza

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale di Piacenza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality
Primary	Mortality and Morbidity
Primary	Left ventricular function
Secondary	Left ventricular remodeling
Secondary	Heart rate variability
Secondary	Baroreflex sensitivity
Secondary	Stress induced myocardial ischemia
Secondary	Cell dose response

External Links

•   Azienda USL Piacenza web site