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

CompletadoFase 1ClinicalTrials.gov

ID: NCT00507468Tipo: INTERVENTIONALInicio: 1 de dic de 2005Fin estimado: 1 de ago de 2009

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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.

Ubicaciones

Swiss Clinic

Buenos Aires, Argentina

Argentine Institute of Diagnosis and Treatment

Buenos Aires, Argentina

Patrocinadores

PrincipalBioCardia, Inc.

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