Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE February 20, 2007
First Posted Date  ICMJE February 21, 2007
Last Update Posted Date March 24, 2010
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
  • Mortality
  • Mortality and Morbidity
  • Left ventricular function
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00437710 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
  • Left ventricular remodeling
  • Heart rate variability
  • Baroreflex sensitivity
  • Stress induced myocardial ischemia
  • Cell dose response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction
Official Title  ICMJE Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans
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

Detailed Description Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE Procedure: cell therapy, bone marrow derived stem cell
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 20, 2007)
50
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00437710
Other Study ID Numbers  ICMJE 01/2007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Azienda Unità Sanitaria Locale di Piacenza
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Massimo Piepoli, MD, PhD G. da Saliceto Hospital, Regional Health Authority
PRS Account Azienda Unità Sanitaria Locale di Piacenza
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP