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

Myocardial Infarction Clinical Trial

— TABMMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507468
• Other study ID #: ABM-MI-10
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2007
• Last updated: November 2, 2009
• Start date: December 2005
• Est. completion date: August 2009

Study information

• Verified date: November 2009
• Source: BioCardia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Ventricular Dysfunction

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Argentina	Argentine Institute of Diagnosis and Treatment	Buenos Aires
Argentina	Swiss Clinic	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
BioCardia, Inc.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of treatment		6 months	Yes