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

November 2, 2009 updated by: BioCardia, Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1118
        • Swiss Clinic
      • Buenos Aires, Argentina, 1122
        • Argentine Institute of Diagnosis and Treatment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of treatment
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCardia, Inc.

Investigators

  • Principal Investigator: Luis de la Fuente, MD, Argentine Institute of Diagnosis and Treatment

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 22, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (Estimate)

July 26, 2007

Study Record Updates

Last Update Posted (Estimate)

November 3, 2009

Last Update Submitted That Met QC Criteria

November 2, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABM-MI-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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