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Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone (TABMMI)

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: NCT00507468
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : November 3, 2009
Sponsor:
Information provided by:
BioCardia, Inc.

Study Description
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Brief Summary:

The object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle transendocardial (TE) delivery system in stable coronary patients with ventricular dysfunction due to chronic myocardial infarction (MI).

A secondary goal was to assess the possibility that such cell injections could improve ejection fraction (EF).


Condition or disease Intervention/treatment Phase
Ventricular Dysfunction Myocardial Infarction Procedure: Transendocaridal Transplantation of Autologous Bone Marrow Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
Study Start Date : December 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Intervention Details:
  • Procedure: Transendocaridal Transplantation of Autologous Bone Marrow
    Single treatment, harvest and transplant of patients own bone marrow. Cells are delivered to the myocardium via transendocardial delivery catheter.

Outcome Measures
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Primary Outcome Measures :
  1. Safety of treatment [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be 18 years of age or older
  • Able to give informed consent
  • Must have documentation of prior myocardial infarction with left ventricular ejection fraction of less than 40 percent at baseline
  • Must be a candidate for percutaneous heart catheterization
  • Must have identifiable area of transmural scar within the left ventricle

Exclusion Criteria:

  • Be a candidate for concurrent ventricular surgical restoration, AICD placement or valvular surgery
  • Clinical evidence of infection
  • Other complicating cardiovascular abnormalities
  • Clinically significant electrocardiographic abnormalities
  • Active malignancy
  • Recent history or drug or alcohol abuse
  • Pregnancy, planned or current
  • Artificial aortic valve
  • Ejection fraction less than 30 percent at baseline
  • Myocardial infarction in the past 4 weeks
Contacts and Locations
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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): NCT00507468


Locations
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Argentina
Swiss Clinic
Buenos Aires, Argentina, 1118
Argentine Institute of Diagnosis and Treatment
Buenos Aires, Argentina, 1122
Sponsors and Collaborators
BioCardia, Inc.
Investigators
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Principal Investigator: Luis de la Fuente, MD Argentine Institute of Diagnosis and Treatment
More Information
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Responsible Party: Peter Altman, BioCardia, Inc
ClinicalTrials.gov Identifier: NCT00507468    
Other Study ID Numbers: ABM-MI-10
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: November 3, 2009
Last Verified: November 2009
Keywords provided by BioCardia, Inc.:
bone marrow
autologous
ejection fraction
left ventricle
 heart attack
myocardial infarction
left ventricular dysfunction post myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Ventricular Dysfunction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases