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)

Result code in 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>

Result on the web

<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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Result language

angličtina

Original language name

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)

Original language description

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.

Czech name

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Czech description

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Type

J_ost - Miscellaneous article in a specialist periodical

CEP classification

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OECD FORD branch

30212 - Surgery

Project

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Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2021

Confidentiality

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

Name of the periodical

Clinics in surgeryTM

ISSN

2474-1647

e-ISSN

2474-1647

Volume of the periodical

6

Issue of the periodical within the volume

article 3303

Country of publishing house

US - UNITED STATES

Number of pages

7

Pages from-to

1-7

UT code for WoS article

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EID of the result in the Scopus database

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