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

NCT ID: NCT00507468

Last Updated: 2009-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2009-08-31

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).

Conditions

Ventricular Dysfunction; Myocardial Infarction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Transendocaridal 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioCardia, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

BioCardia, Inc

Principal Investigators

Luis de la Fuente, MD

Role: PRINCIPAL_INVESTIGATOR

Argentine Institute of Diagnosis and Treatment

Locations

Swiss Clinic

Buenos Aires, , Argentina

Argentine Institute of Diagnosis and Treatment

Buenos Aires, , Argentina

Countries

Argentina

Other Identifiers

ABM-MI-10

Identifier Type: -

Identifier Source: org_study_id