Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
This study has been completed.
Sponsor:
Assaf-Harofeh Medical Center
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 30, 2009 | ||||
| Last Updated Date | July 6, 2009 | ||||
| Start Date ICMJE | April 2003 | ||||
| Primary Completion Date | May 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Procedure success [ Time Frame: 9 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00933621 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Functional class improvement [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up | ||||
| Official Title ICMJE | Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Chronic Ischemic Symptomatic Heart Failure | ||||
| Intervention ICMJE | Procedure: Autologous bone marrow intracoronary infusion
Percutaneous intracoronary mononuclear bone marrow cell infusion
Other Name: Intracoronary mononuclear bone marrow cell infusion |
||||
| Study Arm (s) | Experimental: Autologous Bone Marrow infusion
Percutaneous intracoronary autologous bone marrow infusion
Intervention: Procedure: Autologous bone marrow intracoronary infusion |
||||
| 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | December 2003 | ||||
| Primary Completion Date | May 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 88 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00933621 | ||||
| Other Study ID Numbers ICMJE | 19-03 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Alex Blatt, Assaf Harofeh MC | ||||
| Study Sponsor ICMJE | Assaf-Harofeh Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Assaf-Harofeh Medical Center | ||||
| Verification Date | July 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||