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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 22, 2007

Last Updated Date

April 1, 2008

Start Date ^†

December 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00507468 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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).

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^†

Ventricular Dysfunction
Myocardial Infarction

Intervention ^†

Procedure: Transendocaridal Transplantation of Autologous Bone Marrow

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

August 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Argentina

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00507468

Responsible Party

Peter Altman, BioCardia, Inc

Secondary IDs ^††

Study Sponsor ^†

BioCardia, Inc.

Collaborators ^††

Investigators ^†

Principal Investigator:

Luis de la Fuente, MD

Argentine Institute of Diagnosis and Treatment

Information Provided By

BioCardia, Inc.

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.