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Buněčná léčba u těžké ischémie: protokol systematického review typu „umbrella“
Title in English | Autologous cell therapy in chronic limb-threatening ischemia: an umbrella review protocol |
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Authors | |
Year of publication | 2020 |
Type | Article in Periodical |
Magazine / Source | Zdravotnícké Listy |
MU Faculty or unit | |
Citation | |
Web | https://zl.tnuni.sk/fileadmin/Archiv/2020/2020-8.c.4/ZL_2020_8_4_04_Klugar1.pdf |
Keywords | Autologous cell therapy; Critical limb ischemia; Peripheral arterial disease; Meta-analysis; Umbrella review |
Description | Background: Chronic limb-threatening ischemia is a condition linked with peripheral arterial disease mainly resulting from diabetes mellitus, and a few other diseases. Some patients are not candidates for standard revascularization treatment procedures and those have a substantially increased rate of major amputations and mortality. Autologous Cell Therapy seems to be a safe and effective option to foster angiogenesis and healing. The outcomes of previous systematic reviews are not conclusive and umbrella review is warranted. Objective: The objective of this umbrella review will be to investigate the effects of autologous cell therapy on the ischemic parameters and the rate of high amputations in patients with critical limb ischemia. Inclusion criteria: Population - the patients of all ages with chronic limb-threatening ischemia or peripheral arterial disease (in diabetic and non-diabetic patients) will be included. Intervention - Autologous Cell Therapy. Comparison - standard therapy (any type of alternative therapy) or placebo. Outcomes - efficacy of the intervention (ischemic parameters: ABI, TBI, TpCCte, pain), safety, risk of high amputation, wound healing parameters. Only systematic reviews will be included. Methods: We will follow the methodology of the Joanna Briggs Institute for umbrella reviews. We will search ten databases by Epistemonikos platform to identify any relevant systematic reviews. No language or geographical limit will be applied. Two independent reviewers will carry out screening, critical appraisal, and data extraction. The results will be presented in a tabular and narrative form, and meta-analysis will be performed. The certainty of evidence will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. |