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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00507468

Acronym

TABMMI

Enrollment

Registered

2007-07-26

Start date

2005-12-31

Completion date

2009-08-31

Last updated

2009-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, Ventricular Dysfunction

Keywords

bone marrow, autologous, ejection fraction, left ventricle, heart attack, myocardial infarction, left ventricular dysfunction post myocardial infarction

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).

Interventions

PROCEDURETransendocaridal 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety of treatment	6 months

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026