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OpenTrials
Completed

NCT Number: NCT00507468

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

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).

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Key information

Conditions

Ventricular Dysfunction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Argentine Institute of Diagnosis and Treatment, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transendocaridal Transplantation of Autologous Bone Marrow

Procedure

Single treatment, harvest and transplant of patients own bone marrow. Cells are delivered to the myocardium via transendocardial delivery catheter.

Primary outcomes

  1. Safety of treatment

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

BioCardia, Inc.

Industry

Registry information

Acronym: TABMMI

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jul 26, 2007
Registry last updated
Nov 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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