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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Azienda Unità Sanitaria Locale di Piacenza.
Recruitment status was:  Recruiting
Information provided by:
Azienda Unità Sanitaria Locale di Piacenza Identifier:
First received: February 20, 2007
Last updated: March 23, 2010
Last verified: February 2007

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

Condition Intervention Phase
Acute Myocardial Infarction
Procedure: cell therapy, bone marrow derived stem cell
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans

Resource links provided by NLM:

Further study details as provided by Azienda Unità Sanitaria Locale di Piacenza:

Primary Outcome Measures:
  • Mortality
  • Mortality and Morbidity
  • Left ventricular function

Secondary Outcome Measures:
  • Left ventricular remodeling
  • Heart rate variability
  • Baroreflex sensitivity
  • Stress induced myocardial ischemia
  • Cell dose response

Estimated Enrollment: 50
Study Start Date: July 2005
Estimated Study Completion Date: February 2007
Detailed Description:
Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00437710

Contact: Massimo Piepoli, MD, PhD +390 523 303217
Contact: Daniele Vallisa, MD +390 523 303737

G da Saliceto Hospital Recruiting
Piacenza, Italy, 29100
Contact: Massimo Piepoli, MD    +390 523 303217   
Contact: Daniele Vallisa, MD    +390 523 303737   
Principal Investigator: Massimo Piepoli, MD, PhD         
Sponsors and Collaborators
Azienda Unità Sanitaria Locale di Piacenza
Principal Investigator: Massimo Piepoli, MD, PhD G. da Saliceto Hospital, Regional Health Authority
  More Information

Additional Information: Identifier: NCT00437710     History of Changes
Other Study ID Numbers: 01/2007
Study First Received: February 20, 2007
Last Updated: March 23, 2010

Keywords provided by Azienda Unità Sanitaria Locale di Piacenza:
bone marrow, cell transplantation, stem cells, PTCA

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on April 26, 2017