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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:
ClinicalTrials.gov Identifier:
NCT00933621
First Posted: July 7, 2009
Last Update Posted: July 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
June 30, 2009
July 7, 2009
July 7, 2009
April 2003
May 2003   (Final data collection date for primary outcome measure)
Procedure success [ Time Frame: 9 months ]
Same as current
No Changes Posted
Functional class improvement [ Time Frame: 9 months ]
Same as current
Not Provided
Not Provided
 
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Ischemic Symptomatic Heart Failure
Procedure: Autologous bone marrow intracoronary infusion
Percutaneous intracoronary mononuclear bone marrow cell infusion
Other Name: Intracoronary mononuclear bone marrow cell infusion
Experimental: Autologous Bone Marrow infusion
Percutaneous intracoronary autologous bone marrow infusion
Intervention: Procedure: Autologous bone marrow intracoronary infusion
Abdel-Latif A, Bolli R, Tleyjeh IM, et al. Adult bone marrow-derived cells for cardiac repair. Arch Intern Med. 2007;167:989-997. 12. Murry CE, Reinecke H and Pabon LM. Regeneration Gaps: Observation on stem cells and cardiac repair. J Am Coll Cardiol. 2006;47:1777-1785.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2003
May 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 88 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00933621
19-03
No
Not Provided
Not Provided
Alex Blatt, Assaf Harofeh MC
Assaf-Harofeh Medical Center
Not Provided
Principal Investigator: Alex Blatt, MD Assaf Harofeh MC
Assaf-Harofeh Medical Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP