Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
Phase 1
Completed
- Conditions
- Ventricular DysfunctionMyocardial Infarction
- Registration Number
- NCT00507468
- Lead Sponsor
- BioCardia, Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety of treatment 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Swiss Clinic
🇦🇷Buenos Aires, Argentina
Argentine Institute of Diagnosis and Treatment
🇦🇷Buenos Aires, Argentina