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)

František Jalůvka1,2, Jan Roman1,2, Kateřina Vítková3, Jaromír Gumulec2,4, Adéla Vrtková5, Lubomír Pavliska3, Kusinová Pavlína6 and Václav Procházka6,7*

1Department of Surgery, University Hospital Ostrava, Czech Republic
2Department of Surgical Studies, Faculty of Medicine, Czech Republic
3Department of Science and Research Deputy, University Hospital Ostrava, Czech Republic
4Department of Hemato-Oncology, University Hospital Ostrava, Czech Republic
5Department of Applied Mathematics, Faculty of Electrical Engineering and Computer Science, VSB – Technical University of Ostrava, Czech Republic
6Department of Radiology, University Hospital Ostrava, Czech Republic
7Department of Imaging Methods, Faculty of Medicine, Czech Republic

^*Correspondance to: Václav Procházka 

 PDF  Full Text DOI: 10.25107/2474-1647.3303

Abstract

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.

Keywords

Cite the article

Jalůvka F, Roman J, Vítková K, Gumulec J, Vrtková A, Pavliska L, et al. 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). Clin Surg. 2021; 6: 3303..