Long-Term and Sustained Therapeutic Results of a Specific Promonocyte Cell Formulation in Refractory Angina: ReACT (Refractory Angina Cell Therapy) Clinical Update and Cost-Effective Analysis
| Autor: | Cruz E, Rodrigues de Oliveira Js, Regina Coeli dos Santos Goldenberg, Paul R. Sanberg, Coimbra Ac, Leslie W. Miller, Noedir Antônio Groppo Stolf, Enio Buffolo, Regazzi G, Rodrigues Branco Jn, Janaína José dos Santos Machado, Nelson Americo Hossne, Silvia P. Azevedo, Adriana Luckow Invitti |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Angiogenesis Cost-Benefit Analysis Population Myocardial Ischemia Biomedical Engineering lcsh:Medicine Monocyte-Macrophage Precursor Cells Peripheral blood mononuclear cell Statistics Nonparametric Angina Pectoris Angina Cell therapy Percutaneous Coronary Intervention Surveys and Questionnaires Internal medicine medicine Humans Radionuclide Imaging education Aged Transplantation education.field_of_study business.industry Myocardium lcsh:R Cell Biology Canadian Cardiovascular Society Length of Stay Middle Aged medicine.disease Surgery Clinical trial Quality of Life Cardiology Female Stem cell business Follow-Up Studies |
| Zdroj: | Cell Transplantation, Vol 24 (2015) |
| ISSN: | 1555-3892 0963-6897 |
| Popis: | Mononuclear stem cells have been studied for their potential in myocardial ischemia. In our previous published article, ReACT® phase I/II clinical trial, our results suggest that a certain cell population, promonocytes, directly correlated with the perceived angiogenesis in refractory angina patients. This study is ReACT's clinical update, assessing long-term sustained efficacy. The ReACT phase IIA/B noncontrolled, open-label, clinical trial enrolled 14 patients with refractory angina and viable ischemic myocardium, without ventricular dysfunction, who were not suitable for myocardial revascularization. The procedure consisted of direct myocardial injection of a specific mononuclear cell formulation, with a certain percentage of promonocytes, in a single series of multiple injections (24—90; 0.2 ml each) into specific areas of the left ventricle. Primary endpoints were Canadian Cardiovascular Society Angina Classification (CCSAC) improvement at the 12-month follow-up and ischemic area reduction (scintigraphic analysis) at the 12-month follow-up, in correlation with ReACT's formulation. A recovery index (for patients with more than 1 year follow-up) was created to evaluate CCSAC over time, until April 2011. Almost all patients presented progressive improvement in CCSAC beginning 3 months ( p = 0.002) postprocedure, which was sustained at the 12-month follow-up ( p = 0.002), as well as objective myocardium ischemic area reduction at 6 months (decrease of 15%, p < 0.024) and 12 months (decrease of 100%, p < 0.004) The recovery index ( n = 10) showed that the patients were graded less than CCSAC 4 for 73.9 ± 24.2% over a median follow-up time of 46.8 months. After characterization, ReACT's promonocyte concentration suggested a positive correlation with CCSAC improvement ( r = −0.575, p = 0.082). Quality of life (SF-36 questionnaire) improved significantly in almost all domains. Cost-effectiveness analysis showed decrease in angina-related direct costs. Refractory angina patients presented a sustained long-term improvement in CCSAC and myocardium ischemic areas after the procedure. The long-term follow-up and strong improvement in quality of life reinforce effectiveness. Promonocytes may play a key role in myocardial neoangiogenesis. ReACT dramatically decreased direct costs. |
| Databáze: | OpenAIRE |
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