Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00507468
NCT00507468
Completed
Phase 1

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

BioCardia, Inc.2 sites in 1 country20 target enrollmentDecember 2005
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsVentricular DysfunctionMyocardial Infarction

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Ventricular Dysfunction
Sponsor
BioCardia, Inc.
Enrollment
20
Locations
2
Primary Endpoint
Safety of treatment
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
August 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety of treatment

Time Frame: 6 months

Study Sites (2)

Loading locations...

Similar Trials

Completed
Phase 1
Study of Autologous Stem Cell Transplantation for Patients With Ischemic StrokeInfarction, Middle Cerebral Artery
NCT00473057Universidade Federal do Rio de Janeiro12
Completed
Phase 1
Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisALS
NCT01363401Corestemchemon, Inc.72
Completed
Phase 2
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated CardiomyopathyDilated Cardiomyopathy
NCT00743639Instituto de Cardiologia do Rio Grande do Sul30
Unknown
Phase 2
Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery InfarctMiddle Cerebral Artery Infarction
NCT01461720National University of Malaysia50
Completed
Phase 1
Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple SclerosisMultiple Sclerosis
NCT01933802Tisch Multiple Sclerosis Research Center of New York20