Randomized clinical trial of the safety and efficacy of autologous bone marrow aspirate concentrate for no-option critical limb ischemia in type 2 diabetes mellitus patients (DIALEG)

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F21%3AE0109192" target="_blank" >RIV/00843989:_____/21:E0109192 - isvavai.cz</a>

Výsledek na webu

<a href="http://www.clinicsinsurgery.com/open-access/randomized-clinical-trial-of-the-safety-and-efficacy-of-autologous-7886.pdf" target="_blank" >http://www.clinicsinsurgery.com/open-access/randomized-clinical-trial-of-the-safety-and-efficacy-of-autologous-7886.pdf</a>

DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Randomized clinical trial of the safety and efficacy of autologous bone marrow aspirate concentrate for no-option critical limb ischemia in type 2 diabetes mellitus patients (DIALEG)

Popis výsledku v původním jazyce

Introduction: Critical limb ischemia is one of the major vascular complications of long-lasting type 2 diabetes mellitus. Application of autologous Bone Marrow Aspiration Concentrate (BMAC) appears to be a possible treatment to improve the outcomes of patients for whom there is no other treatment option for critical limb ischemia. Objectives: The objective of the study was to evaluate the safety, tolerability, and efficacy of different routes of administration of Bone Marrow Mononuclear Cells (BM-MNC) in patients with otherwise insoluble Critical Limb Ischemia (NO-CLI) in the field of type 2 diabetes mellitus. Design: Single centre parallel randomized controlled open label trial. Computer generated tables were used to allocate treatment methods. Participants: 55 patients with a history of type 2 diabetes mellitus with critical limb ischemia with depleted standard treatment were evaluated. Intervention: Single application of autologous bone marrow aspirate concentrates intramuscularly, intra-arterially, or intravenously. Patients were monitored for 2 years at predetermined intervals. Conclusion: The application of BM-MNC statistically significantly prolongs the overall survival of patients without dependence on the route of application and improves the quality of life, but at the same time does not significantly reduce the frequency of limb amputations.

Název v anglickém jazyce

Randomized clinical trial of the safety and efficacy of autologous bone marrow aspirate concentrate for no-option critical limb ischemia in type 2 diabetes mellitus patients (DIALEG)

Popis výsledku anglicky

Introduction: Critical limb ischemia is one of the major vascular complications of long-lasting type 2 diabetes mellitus. Application of autologous Bone Marrow Aspiration Concentrate (BMAC) appears to be a possible treatment to improve the outcomes of patients for whom there is no other treatment option for critical limb ischemia. Objectives: The objective of the study was to evaluate the safety, tolerability, and efficacy of different routes of administration of Bone Marrow Mononuclear Cells (BM-MNC) in patients with otherwise insoluble Critical Limb Ischemia (NO-CLI) in the field of type 2 diabetes mellitus. Design: Single centre parallel randomized controlled open label trial. Computer generated tables were used to allocate treatment methods. Participants: 55 patients with a history of type 2 diabetes mellitus with critical limb ischemia with depleted standard treatment were evaluated. Intervention: Single application of autologous bone marrow aspirate concentrates intramuscularly, intra-arterially, or intravenously. Patients were monitored for 2 years at predetermined intervals. Conclusion: The application of BM-MNC statistically significantly prolongs the overall survival of patients without dependence on the route of application and improves the quality of life, but at the same time does not significantly reduce the frequency of limb amputations.

Druh

J_ost - Ostatní články v recenzovaných periodicích

CEP obor

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OECD FORD obor

30212 - Surgery

Projekt

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Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Clinics in surgeryTM

ISSN

2474-1647

e-ISSN

2474-1647

Svazek periodika

6

Číslo periodika v rámci svazku

article 3303

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

7

Strana od-do

1-7

Kód UT WoS článku

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EID výsledku v databázi Scopus

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