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Combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia
INTRODUCTION: Our study was designed to investigate the safety and efficacy of combined autologous bone marrow mononuclear cell (MNC) and gene therapy in comparison to conventional drug therapy in patients with critical limb ischemia (CLI). MATERIAL AND METHODS: Thirty-two patients with CLI persisti...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Termedia Publishing House
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4424239/ https://www.ncbi.nlm.nih.gov/pubmed/25995748 http://dx.doi.org/10.5114/aoms.2013.39935 |
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author | Skóra, Jan Pupka, Artur Janczak, Dariusz Barć, Piotr Dawiskiba, Tomasz Korta, Krzysztof Baczyńska, Dagmara Mastalerz-Migas, Agnieszka Garcarek, Jerzy |
author_facet | Skóra, Jan Pupka, Artur Janczak, Dariusz Barć, Piotr Dawiskiba, Tomasz Korta, Krzysztof Baczyńska, Dagmara Mastalerz-Migas, Agnieszka Garcarek, Jerzy |
author_sort | Skóra, Jan |
collection | PubMed |
description | INTRODUCTION: Our study was designed to investigate the safety and efficacy of combined autologous bone marrow mononuclear cell (MNC) and gene therapy in comparison to conventional drug therapy in patients with critical limb ischemia (CLI). MATERIAL AND METHODS: Thirty-two patients with CLI persisting for 12–48 months (average time 27.5 months) were randomized into 2 groups, each group consisting of 16 patients. In the first group, administration of autologous bone marrow MNC and vascular endothelial growth factor (VEGF) plasmid was performed. The patients from the second group were treated pharmacologically with pentoxifylline. Ankle-brachial index (ABI) was measured and angiography was performed before and finally 3 months after treatment. The pain was evaluated using the Visual Analog Scale (VAS) before and after 3 months. RESULTS: Ankle-brachial index improved significantly from 0.29 ±0.21 to 0.52 ±0.23 (p < 0.001) in 12 patients (75.0%) 3 months after the experimental therapy in group 1. In this group angiography showed the development of collateral vessels. Ischemic ulcers healed completely in 11 patients (68.75%). In group 2 the ABI did not improve in any patient; moreover the complete healing of skin ulcers was not found in any of the patients of this group. Amputation was performed in 4 (25.0%) patients in group 1, and in 8 patients (50%) from group 2. CONCLUSIONS: These data after 3-month follow-up indicate that intramuscular injection of MNC combined with gene therapy in patients with chronic CLI is safe, and a more feasible and effective method of treatment than the conventional therapy. However, both therapies are limited by the degree of microcirculation damage. |
format | Online Article Text |
id | pubmed-4424239 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Termedia Publishing House |
record_format | MEDLINE/PubMed |
spelling | pubmed-44242392015-05-20 Combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia Skóra, Jan Pupka, Artur Janczak, Dariusz Barć, Piotr Dawiskiba, Tomasz Korta, Krzysztof Baczyńska, Dagmara Mastalerz-Migas, Agnieszka Garcarek, Jerzy Arch Med Sci Clinical Research INTRODUCTION: Our study was designed to investigate the safety and efficacy of combined autologous bone marrow mononuclear cell (MNC) and gene therapy in comparison to conventional drug therapy in patients with critical limb ischemia (CLI). MATERIAL AND METHODS: Thirty-two patients with CLI persisting for 12–48 months (average time 27.5 months) were randomized into 2 groups, each group consisting of 16 patients. In the first group, administration of autologous bone marrow MNC and vascular endothelial growth factor (VEGF) plasmid was performed. The patients from the second group were treated pharmacologically with pentoxifylline. Ankle-brachial index (ABI) was measured and angiography was performed before and finally 3 months after treatment. The pain was evaluated using the Visual Analog Scale (VAS) before and after 3 months. RESULTS: Ankle-brachial index improved significantly from 0.29 ±0.21 to 0.52 ±0.23 (p < 0.001) in 12 patients (75.0%) 3 months after the experimental therapy in group 1. In this group angiography showed the development of collateral vessels. Ischemic ulcers healed completely in 11 patients (68.75%). In group 2 the ABI did not improve in any patient; moreover the complete healing of skin ulcers was not found in any of the patients of this group. Amputation was performed in 4 (25.0%) patients in group 1, and in 8 patients (50%) from group 2. CONCLUSIONS: These data after 3-month follow-up indicate that intramuscular injection of MNC combined with gene therapy in patients with chronic CLI is safe, and a more feasible and effective method of treatment than the conventional therapy. However, both therapies are limited by the degree of microcirculation damage. Termedia Publishing House 2014-07-23 2015-04-25 /pmc/articles/PMC4424239/ /pubmed/25995748 http://dx.doi.org/10.5114/aoms.2013.39935 Text en Copyright © 2015 Termedia & Banach http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License, permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Clinical Research Skóra, Jan Pupka, Artur Janczak, Dariusz Barć, Piotr Dawiskiba, Tomasz Korta, Krzysztof Baczyńska, Dagmara Mastalerz-Migas, Agnieszka Garcarek, Jerzy Combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia |
title | Combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia |
title_full | Combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia |
title_fullStr | Combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia |
title_full_unstemmed | Combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia |
title_short | Combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia |
title_sort | combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia |
topic | Clinical Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4424239/ https://www.ncbi.nlm.nih.gov/pubmed/25995748 http://dx.doi.org/10.5114/aoms.2013.39935 |
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