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

NCT00507468 | Completed Phase 1 DMC

• 1 other identifier: ABM-MI-10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety of treatment

  6 months

Interventions

Transendocaridal Transplantation of Autologous Bone Marrow PROCEDURE

Single treatment, harvest and transplant of patients own bone marrow. Cells are delivered to the myocardium via transendocardial delivery catheter.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCardia, Inc.: lead

Study Sites (2)

Swiss Clinic

Buenos Aires, 1118, Argentina

Location

Argentine Institute of Diagnosis and Treatment

Buenos Aires, 1122, Argentina

Location

MeSH Terms

Conditions

Ventricular Dysfunction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Luis de la Fuente, MD

  Argentine Institute of Diagnosis and Treatment

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 22, 2007
• First Posted: July 26, 2007
• Study Start: December 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 3, 2009

Record last verified: 2009-11

Locations

AR (2)