Chronic Ischemic Symptomatic Heart Failure Clinical Trial
Official title:
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
| Verified date | July 2009 |
| Source | Assaf-Harofeh Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | December 2003 |
| Est. primary completion date | May 2003 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 88 Years |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assaf Harofeh | Zerifin |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Procedure success | 9 months | Yes | |
| Secondary | Functional class improvement | 9 months | No |