Assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. Results from a randomized, blind, placebo-controlled trial (TAMIS)
Aim: to assess the safety of transplantation of autologous bone marrow mononuclear cells when performing coronary artery bypass grafting in the combined treatment of ischemic heart disease in patients with coronary and heart failure.Materials and methods. During the period from 2013 to 2016 years 11...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | Russian |
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Federal Research Center of Transplantology and Artificial Organs named after V.I.Shumakov
2019-07-01
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| Series: | Vestnik Transplantologii i Iskusstvennyh Organov |
| Subjects: | |
| Online Access: | https://journal.transpl.ru/vtio/article/view/1027 |
| _version_ | 1797871999861653504 |
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| author | V. V. Komok N. S. Bunenkov S. A. Beliy V. M. Pizin V. M. Kondratev А. V. Dulaev V. I. Lukashenko A. E. Kobak T. S. Maksimova I. P. Sergienko E. V. Parusova L. A. Smirnova E. V. Babenko B. V. Afanasev A. S. Nemkov G. G. Khubulava |
| author_facet | V. V. Komok N. S. Bunenkov S. A. Beliy V. M. Pizin V. M. Kondratev А. V. Dulaev V. I. Lukashenko A. E. Kobak T. S. Maksimova I. P. Sergienko E. V. Parusova L. A. Smirnova E. V. Babenko B. V. Afanasev A. S. Nemkov G. G. Khubulava |
| author_sort | V. V. Komok |
| collection | DOAJ |
| description | Aim: to assess the safety of transplantation of autologous bone marrow mononuclear cells when performing coronary artery bypass grafting in the combined treatment of ischemic heart disease in patients with coronary and heart failure.Materials and methods. During the period from 2013 to 2016 years 117 patients, who meet the established criteria, were included in the work. Randomization was performed in observation groups: group 0 -control group (coronary artery bypass grafting (CABG) and intramyocardial administration of a 0.9% NaCl solution), group 1 - CABG surgery and intramyocardial administration of autologous bone marrow mononuclear cells (ABMMS), group 2 - CABG surgery and intramyocardial and intragraft administration of ABMMS. Clinical, laboratory - CPK MB, myoglobin, troponin I, HCT, Hb, K +, ABC; instrumental (stress tests, echocardiography, speckle tracking, coronary angiography) data were evaluated in these groups. The analysis of the frequency of postoperative complications (hydrothorax, hydropericardium, rhythm disturbances) was performed; the length of stay in the intensive care unit, the length of stay in the hospital and other indicators. After 6 and 12 months, the overall mortality was assessed, major cardiac events - the development of acute myocardial infarction, ventricular arrhythmias, oncological alertness. Number in international register clinical trials Clinical Trial. gov Identifier: NCT02059512.Results. Statistical analysis showed no statistically significant differences in the observation groups for the compared criteria.Conclusion. Transplantation of autologous bone marrow mononuclear cells during aorto-coronary bypass surgery in the combined treatment of coronary heart disease is a safe method. |
| first_indexed | 2024-04-10T00:51:55Z |
| format | Article |
| id | doaj.art-60b44a18654d4093bea3e863fe3d9fcf |
| institution | Directory Open Access Journal |
| issn | 1995-1191 |
| language | Russian |
| last_indexed | 2024-04-10T00:51:55Z |
| publishDate | 2019-07-01 |
| publisher | Federal Research Center of Transplantology and Artificial Organs named after V.I.Shumakov |
| record_format | Article |
| series | Vestnik Transplantologii i Iskusstvennyh Organov |
| spelling | doaj.art-60b44a18654d4093bea3e863fe3d9fcf2023-03-13T10:37:25ZrusFederal Research Center of Transplantology and Artificial Organs named after V.I.ShumakovVestnik Transplantologii i Iskusstvennyh Organov1995-11912019-07-0121211212010.15825/1995-1191-2019-2-112-120790Assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. Results from a randomized, blind, placebo-controlled trial (TAMIS)V. V. Komok0N. S. Bunenkov1S. A. Beliy2V. M. Pizin3V. M. Kondratev4А. V. Dulaev5V. I. Lukashenko6A. E. Kobak7T. S. Maksimova8I. P. Sergienko9E. V. Parusova10L. A. Smirnova11E. V. Babenko12B. V. Afanasev13A. S. Nemkov14G. G. Khubulava15I.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityI.P. Pavlov First Saint Petersburg State Medical UniversityAim: to assess the safety of transplantation of autologous bone marrow mononuclear cells when performing coronary artery bypass grafting in the combined treatment of ischemic heart disease in patients with coronary and heart failure.Materials and methods. During the period from 2013 to 2016 years 117 patients, who meet the established criteria, were included in the work. Randomization was performed in observation groups: group 0 -control group (coronary artery bypass grafting (CABG) and intramyocardial administration of a 0.9% NaCl solution), group 1 - CABG surgery and intramyocardial administration of autologous bone marrow mononuclear cells (ABMMS), group 2 - CABG surgery and intramyocardial and intragraft administration of ABMMS. Clinical, laboratory - CPK MB, myoglobin, troponin I, HCT, Hb, K +, ABC; instrumental (stress tests, echocardiography, speckle tracking, coronary angiography) data were evaluated in these groups. The analysis of the frequency of postoperative complications (hydrothorax, hydropericardium, rhythm disturbances) was performed; the length of stay in the intensive care unit, the length of stay in the hospital and other indicators. After 6 and 12 months, the overall mortality was assessed, major cardiac events - the development of acute myocardial infarction, ventricular arrhythmias, oncological alertness. Number in international register clinical trials Clinical Trial. gov Identifier: NCT02059512.Results. Statistical analysis showed no statistically significant differences in the observation groups for the compared criteria.Conclusion. Transplantation of autologous bone marrow mononuclear cells during aorto-coronary bypass surgery in the combined treatment of coronary heart disease is a safe method.https://journal.transpl.ru/vtio/article/view/1027coronary artery bypass graftingautologous bone marrow mononuclear cellsreperfusion myocardial damageischemic heart diseasediastolic dysfunction of the left ventricular myocardiumheart failureclinical study |
| spellingShingle | V. V. Komok N. S. Bunenkov S. A. Beliy V. M. Pizin V. M. Kondratev А. V. Dulaev V. I. Lukashenko A. E. Kobak T. S. Maksimova I. P. Sergienko E. V. Parusova L. A. Smirnova E. V. Babenko B. V. Afanasev A. S. Nemkov G. G. Khubulava Assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. Results from a randomized, blind, placebo-controlled trial (TAMIS) Vestnik Transplantologii i Iskusstvennyh Organov coronary artery bypass grafting autologous bone marrow mononuclear cells reperfusion myocardial damage ischemic heart disease diastolic dysfunction of the left ventricular myocardium heart failure clinical study |
| title | Assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. Results from a randomized, blind, placebo-controlled trial (TAMIS) |
| title_full | Assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. Results from a randomized, blind, placebo-controlled trial (TAMIS) |
| title_fullStr | Assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. Results from a randomized, blind, placebo-controlled trial (TAMIS) |
| title_full_unstemmed | Assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. Results from a randomized, blind, placebo-controlled trial (TAMIS) |
| title_short | Assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. Results from a randomized, blind, placebo-controlled trial (TAMIS) |
| title_sort | assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease results from a randomized blind placebo controlled trial tamis |
| topic | coronary artery bypass grafting autologous bone marrow mononuclear cells reperfusion myocardial damage ischemic heart disease diastolic dysfunction of the left ventricular myocardium heart failure clinical study |
| url | https://journal.transpl.ru/vtio/article/view/1027 |
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