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

This study has been completed.
Information provided by:
BioCardia, Inc. Identifier:
First received: July 22, 2007
Last updated: November 2, 2009
Last verified: November 2009

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 Intervention Phase
Ventricular Dysfunction
Myocardial Infarction
Procedure: Transendocaridal Transplantation of Autologous Bone Marrow
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone

Resource links provided by NLM:

Further study details as provided by BioCardia, Inc.:

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

Enrollment: 20
Study Start Date: December 2005
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.

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

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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Please refer to this study by its identifier: NCT00507468

Swiss Clinic
Buenos Aires, Argentina, 1118
Argentine Institute of Diagnosis and Treatment
Buenos Aires, Argentina, 1122
Sponsors and Collaborators
BioCardia, Inc.
Principal Investigator: Luis de la Fuente, MD Argentine Institute of Diagnosis and Treatment
  More Information

Responsible Party: Peter Altman, BioCardia, Inc Identifier: NCT00507468     History of Changes
Other Study ID Numbers: ABM-MI-10
Study First Received: July 22, 2007
Last Updated: November 2, 2009

Keywords provided by BioCardia, Inc.:
bone marrow
ejection fraction
left ventricle
heart attack
myocardial infarction
left ventricular dysfunction post myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Ventricular Dysfunction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on May 25, 2017