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

Primary Purpose

Chronic Ischemic Symptomatic Heart Failure

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Autologous bone marrow intracoronary infusion
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Ischemic Symptomatic Heart Failure

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf Harofeh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Bone Marrow infusion

Arm Description

Percutaneous intracoronary autologous bone marrow infusion

Outcomes

Primary Outcome Measures

Procedure success

Secondary Outcome Measures

Functional class improvement

Full Information

First Posted
June 30, 2009
Last Updated
July 6, 2009
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00933621
Brief Title
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
Official Title
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ischemic Symptomatic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Bone Marrow infusion
Arm Type
Experimental
Arm Description
Percutaneous intracoronary autologous bone marrow infusion
Intervention Type
Procedure
Intervention Name(s)
Autologous bone marrow intracoronary infusion
Other Intervention Name(s)
Intracoronary mononuclear bone marrow cell infusion
Intervention Description
Percutaneous intracoronary mononuclear bone marrow cell infusion
Primary Outcome Measure Information:
Title
Procedure success
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Functional class improvement
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Blatt, MD
Organizational Affiliation
Assaf Harofeh MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh
City
Zerifin
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
16682301
Citation
Murry CE, Reinecke H, Pabon LM. Regeneration gaps: observations on stem cells and cardiac repair. J Am Coll Cardiol. 2006 May 2;47(9):1777-85. doi: 10.1016/j.jacc.2006.02.002. Epub 2006 Apr 17.
Results Reference
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Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up

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