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Sponsored by: |
BioCardia, Inc. |
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Information provided by: | BioCardia, Inc. |
ClinicalTrials.gov Identifier: | NCT00507468 |
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).
Condition | Intervention | Phase |
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Ventricular Dysfunction Myocardial Infarction |
Procedure: Transendocaridal Transplantation of Autologous Bone Marrow |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone |
Estimated Enrollment: | 20 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Argentina | |
Argentine Institute of Diagnosis and Treatment | |
Buenos Aires, Argentina, 1122 | |
Swiss Clinic | |
Buenos Aires, Argentina, 1118 |
Principal Investigator: | Luis de la Fuente, MD | Argentine Institute of Diagnosis and Treatment |
Responsible Party: | BioCardia, Inc ( Peter Altman ) |
Study ID Numbers: | ABM-MI-10 |
Study First Received: | July 22, 2007 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00507468 |
Health Authority: | Argentina: Human Research Bioethics Committee |
bone marrow autologous ejection fraction left ventricle |
heart attack myocardial infarction left ventricular dysfunction post myocardial infarction |
Ventricular Dysfunction Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ventricular Dysfunction, Left Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |