Efficacy, safety and influencing factors of intra-calf muscular injection of bone marrow mononuclear cells in the treatment of type 2 diabetes mellitus-induced lower extremity vascular disease

Hui-Min Zhou; Fan Liu; Ai-Ge Yang; Yu-Qing Guo; Ya-Ru Zhou; Yong-Quan Gu; Bao-Yong Yan; Quan-Hai Li

doi:10.3892/etm.2017.5193

Efficacy, safety and influencing factors of intra-calf muscular injection of bone marrow mononuclear cells in the treatment of type 2 diabetes mellitus-induced lower extremity vascular disease

Exp Ther Med. 2017 Nov;14(5):5177-5185. doi: 10.3892/etm.2017.5193. Epub 2017 Sep 22.

Authors

Hui-Min Zhou¹, Fan Liu¹, Ai-Ge Yang¹, Yu-Qing Guo¹, Ya-Ru Zhou², Yong-Quan Gu³, Bao-Yong Yan⁴, Quan-Hai Li⁴

Affiliations

¹ Department of Endocrinology, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, P.R. China.
² Department of Endocrinology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, P.R. China.
³ Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, P.R. China.
⁴ Cell Therapy Laboratory, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, P.R. China.

Abstract

The efficacy, safety and impact of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) associated with the intra-calf muscular injection of bone marrow mononuclear cells (BMMCs) in the treatment of type 2 diabetes mellitus (T2DM)-induced lower extremity vascular disease (LEVD) were evaluated. Patients with T2DM-LEVD were randomly divided into a control group and BMMCs group to assess the efficacy and safety of the treatment; serum VEGF and bFGF levels were detected. The BMMCs group was divided into superior genicular artery (SGA) and inferior genicular artery (IGA) subgroups as well as low-dose and high-dose subgroups for the comparison of efficacy indices. The BMMCs group exhibited significantly improved indices (P<0.05) compared with the control group and no fatalities or cancer occurred. There were no significant changes in serum VEGF and bFGF levels (P>0.05). The claudication distance in the IGA subgroup was significantly greater that in the SGA subgroup (P<0.05); the low-dose subgroup and the high-dose subgroup did not demonstrate any significant differences in each index (P>0.05). BMMC treatment for T2DM-LEVD was found to be safe and effective and had no significant impact on serum VEGF and bFGF levels in the short term; However, the degree of LEVD may affect its efficacy.

Keywords: autologous bone marrow mononuclear cells; basic fibroblast growth factor; lower extremity vascular disease; transplantation dose; type 2 diabetes mellitus; vascular endothelial growth factor.