Bone marrow-derived mononuclear cell therapy improves ischemia parameters and enhances wound healing in patients with diabetic foot ulcers

Dubský M., Bém R, Němcová A, Jirkovská A, Fejfarová V., Pyšná A., Navrátil K.
Institute for Clinical and Experimental Medicine, Prague, Czech Republic

Aim: Therapeutic vasculogenesis by autologous stem cell therapy (ACT) is a new treatment method for patients with critical limb ischemia (CLI) and diabetic foot ulcers (DFU). The aim of our study was to compare changes of transcutaneous oxygen pressure (TcPO2) and healing of DFU in patients treated by cell therapy and conservatively.
Methods: Forty-five diabetic patients with no-option CLI (TcPO2<30 mm Hg), ulcer size between 0.5 and 7 cm2 with Texas classification 1C-3D treated by cell therapy in our foot clinic over 5 years were included into the study (ACT group). Forty-two patients with the same inclusion criteria treated conservatively during the same period were included into the control group. Both groups did not significantly differ in mean age, gender, glycated hemoglobin and mean diabetes duration. Change of TcPO2 and number of healed patients were assessed after 6, 12, 24 and 36 months.
Results: There was no significant difference in mean size, depth or TEXAS stage of the ulcers and TcPO2 (17.7±10.3 vs. 16.5±9.8 mm Hg) between ACT and control groups at baseline. We observed a significant increase of TcPO2 in all measured intervals from 6 months up to 3 years (change of TcPO2 22 mm Hg; p<0.001) after cell therapy, but no significant increase in control group (change of TcPO2 4 mm Hg). The number of healed patients were significantly higher in ACT group compared to controls after 6 months (34.8 vs. 13.5%, p=0.021), 12 months (43.2 vs. 21.4%, p=0.025) and 24 months (67.5 vs 38.1%, p=0.009). Number of healed patients in 36 months was without a significant difference. 
Conclusions: Our study proved faster wound healing and a significant increase of TcPO2 in diabetic patients with no-option CLI treated by cell therapy in comparison with conservative treatment. Autologous bone marrow-derived mononuclear cell therapy seems to be a promising alternative for treatment of most severe stages of CLI.
Supported by Ministry of Health of the Czech Republic, grant no. 16-27262A, by project for Development of Research Organization 00023001 (IKEM, Prague, Czech Republic) – Institutional support

Autologous cell therapy improves ischemia parameters and enhances wound healing in patients with diabetic foot ulcers