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

March 23, 2010 updated by: Azienda Unita Sanitaria Locale di Piacenza

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Piacenza, Italy, 29100
        • Recruiting
        • G da Saliceto Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Massimo Piepoli, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality
Left ventricular function
Mortality and Morbidity

Secondary Outcome Measures

Outcome Measure
Heart rate variability
Left ventricular remodeling
Baroreflex sensitivity
Stress induced myocardial ischemia
Cell dose response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unita Sanitaria Locale di Piacenza

Investigators

  • Principal Investigator: Massimo Piepoli, MD, PhD, G. da Saliceto Hospital, Regional Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Anticipated)

February 1, 2007

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Estimate)

March 24, 2010

Last Update Submitted That Met QC Criteria

March 23, 2010

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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