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

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ClinicalTrials.gov Identifier: NCT00437710
Recruitment Status : Unknown
Verified February 2007 by Azienda Unità Sanitaria Locale di Piacenza.
Recruitment status was:  Recruiting
First Posted : February 21, 2007
Last Update Posted : March 24, 2010
Sponsor:
Information provided by:
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


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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2005
Estimated Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Mortality
  2. Mortality and Morbidity
  3. Left ventricular function

Secondary Outcome Measures :
  1. Left ventricular remodeling
  2. Heart rate variability
  3. Baroreflex sensitivity
  4. Stress induced myocardial ischemia
  5. Cell dose response


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00437710     History of Changes
Other Study ID Numbers: 01/2007
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: February 2007

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