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Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up

This study has been completed.
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00933621
First received: June 30, 2009
Last updated: July 6, 2009
Last verified: July 2009
History of Changes
  Purpose

The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.


Condition Intervention Phase
Chronic Ischemic Symptomatic Heart Failure
 Procedure: Autologous bone marrow intracoronary infusion
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Procedure success [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Functional class improvement [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: April 2003
Study Completion Date: December 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Bone Marrow infusion
Percutaneous intracoronary autologous bone marrow infusion
 Procedure: Autologous bone marrow intracoronary infusion
Percutaneous intracoronary mononuclear bone marrow cell infusion
Other Name: Intracoronary mononuclear bone marrow cell infusion

Detailed Description:

Several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. There are no data about the long term outcome.

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography

Exclusion Criteria:

  • Idiopathic or non-ischemic cardiomyopathy
  • Other etiology for heart failure, history of past or current disease involving the bone marrow
  • Patients on dialysis
  • Positive serologic test for HIV, hepatitis B or C or any neoplastic or terminal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933621

Locations
Israel
Assaf Harofeh
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Alex Blatt, MD Assaf Harofeh MC
  More Information

Publications:

Responsible Party: Alex Blatt, Assaf Harofeh MC
ClinicalTrials.gov Identifier: NCT00933621     History of Changes
Other Study ID Numbers: 19-03
Study First Received: June 30, 2009
Last Updated: July 6, 2009
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013