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G-CSF-Stimulation And Coronary Reinfusion Of Mobilized Circulating Mononuclear Proangiogenic Cells In Patients With Chronic Ischemic Heart Disease: Five Year Results Of The TOPCARE- G-CSF Trial.
MedLine Citation:
PMID:  22963750     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background: Prognosis of patients with heart failure remains poor despite improved conventional and interventional treatment regimens. The improvement of neovascularisation and repair processes by administration of bone marrow-derived cells modestly improved the recovery after acute myocardial infarction. However, circulating patient-derived cells are reduced in number and function particularly in chronic heart failure. Therefore, we tested the hypothesis whether the mobilisation of circulating mononuclear proangiogenic cells (CPCs) by G-CSF may overcome some of these limitations.Methods: In the present pilot study, 32 patients with at least 3 months old myocardial infarction were randomized to G-CSF alone (G-CSF group) or intracoronary infusion of GCSF-mobilised and cultured CPCs into the infarct-related artery (G-CSF/CPC group). Primary endpoint of the study was safety. Efficacy parameters included serial assessment of LV function, NT-proBNP levels and cardiopulmonary exercise testing.Results: G-CSF effectively mobilised circulating CD34⁺CD45⁺ cells after 5 days in all patients (408 ± 64%) without serious adverse events.At 3 months, NYHA class and global LV function did not show significant improvements in both treatment groups (G-CSF: Δ LVEF 1.6 ± 2.4 %; p = 0.10; G-CSF/CPC: Δ LVEF 1.4 ± 4.1%; p = 0.16). In contrast, target area contractility improved significantly in the G-CSF/CPC group. During 5-year follow-up, 1 patient died after rehospitalisation for worsening heart failure. 11 patients underwent further revascularization procedures. NT-proBNP levels, cardiopulmonary exercise capacity and NYHA class remained stable in both treatment groups.Conclusion: The results from our pilot trial indicate that administration of G-CSF alone or of G-CSF-mobilised and cultured CPCs can be performed safely in patients with chronic ischemic heart disease. However, only minor effects on LV-function, NT-proBNP levels and NYHA classification were observed during follow-up suggesting that the enhancement of CPCs by G-CSF alone does not substantially improve intracoronary cell therapy effects in patients with chronic ischemic heart failure.
Authors:
Joerg Honold; Ulrich Fischer-Rasokat; Ralf Lehmann; David M Leistner; Florian H Seeger; Volker Schachinger; Hans Martin; Stefanie Dimmeler; Andreas M Zeiher; Birgit Assmus
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-7
Journal Detail:
Title:  Cell transplantation     Volume:  -     ISSN:  1555-3892     ISO Abbreviation:  Cell Transplant     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-11     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9208854     Medline TA:  Cell Transplant     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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