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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

June 30, 2009
July 6, 2009
April 2003
May 2003   (final data collection date for primary outcome measure)
Procedure success [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00933621 on ClinicalTrials.gov Archive Site
Functional class improvement [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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, 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.

*   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
Both
18 Years to 88 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00933621
19-03
No
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