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

This study has been completed.

First Received: June 30, 2009 Last Updated: July 6, 2009 History of Changes

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00933621

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety Study
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
Autologous Bone Marrow infusion: Experimental Percutaneous intracoronary autologous bone marrow infusion	Procedure: Autologous bone marrow intracoronary infusion Percutaneous 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:

Abdel-Latif A, Bolli R, Tleyjeh IM, Montori VM, Perin EC, Hornung CA, Zuba-Surma EK, Al-Mallah M, Dawn B. Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis. Arch Intern Med. 2007 May 28;167(10):989-97. Review.

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

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Ischemia

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009