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

This study has been completed.
Sponsor:
Information provided by:
BioCardia, Inc.
ClinicalTrials.gov Identifier:
NCT00507468
First received: July 22, 2007
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

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
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507468

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

No publications provided

Responsible Party: Peter Altman, BioCardia, Inc
ClinicalTrials.gov Identifier: NCT00507468     History of Changes
Other Study ID Numbers: ABM-MI-10
Study First Received: July 22, 2007
Last Updated: November 2, 2009
Health Authority: Argentina: Human Research Bioethics Committee

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:
Infarction
Myocardial Infarction
Ventricular Dysfunction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014