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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 because the information has not been verified recently.
Verified February 2007 by Azienda Unità Sanitaria Locale di Piacenza.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Azienda Unità Sanitaria Locale di Piacenza
ClinicalTrials.gov Identifier:
NCT00437710
First received: February 20, 2007
Last updated: March 23, 2010
Last verified: February 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437710

Contacts
Contact: Massimo Piepoli, MD, PhD +390 523 303217 m.piepoli@ausl.pc.it
Contact: Daniele Vallisa, MD +390 523 303737 d.vallisa@ausl.pc.it

Locations
Italy
G da Saliceto Hospital Recruiting
Piacenza, Italy, 29100
Contact: Massimo Piepoli, MD     +390 523 303217     m.piepoli@ausl.pc.it    
Contact: Daniele Vallisa, MD     +390 523 303737     d.vallisa@ausl.pc.it    
Principal Investigator: Massimo Piepoli, MD, PhD            
Sponsors and Collaborators
Azienda Unità Sanitaria Locale di Piacenza
Investigators
Principal Investigator: Massimo Piepoli, MD, PhD G. da Saliceto Hospital, Regional Health Authority
  More Information

Additional Information:
Azienda USL Piacenza web site  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00437710     History of Changes
Other Study ID Numbers: 01/2007
Study First Received: February 20, 2007
Last Updated: March 23, 2010
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013