Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone - Full Text View

Sponsored by:	BioCardia, Inc.
Information provided by:	BioCardia, Inc.
ClinicalTrials.gov Identifier:	NCT00507468

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 I

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

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

Further study details as provided by BioCardia, Inc.:

Primary Outcome Measures:

Safety of treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Intervention Details:

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

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

Responsible Party:	BioCardia, Inc ( Peter Altman )
Study ID Numbers:	ABM-MI-10
Study First Received:	July 22, 2007
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00507468
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

Study placed in the following topic categories:

Ventricular Dysfunction
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ventricular Dysfunction, Left
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009