Autogenously derived regenerative cell therapy for venous leg ulcers.

INTRODUCTION

Venous leg ulcers (VLUs), which arise from chronic venous insufficiency in the lower limbs, are a major cause of morbidity and significantly negatively impact patients' health-related quality of life. Treatment of venous ulcers can be either conservative or surgical. Despite appropriate treatment, VLUs can be resistant to healing. Clinical results of treatment of venous foot ulcers with adipose-derived autologous stem cells, which did not improve despite the surgical treatment of the underlying venous pathology in the following case series, are reported.

MATERIAL AND METHODS

Between April 2015 and January 2016, a total of 31 patients who had undergone surgery for underlying venous pathology but the venous ulcer had not healed were included in the study. The mean venous ulcer size was 3.6-6.2 cm (range: 2 to 8 cm by 3 to 9 cm). All patients were treated with adipose-derived autologous stem cells prepared using the MyStem Regenerative Adipose-Derived Stem Cell Purification Kit (MyStem LLC, USA). The ulcer diameter was measured and recorded in the third, sixth and twelfth months. The follow-up time was 12 months after ulcer healing.

RESULTS

Eighteen ulcers demonstrated complete healing at the 12 month. Thirteen ulcers exhibited serious contraction and epithelialization even though the ulcer was not completely closed. At the 12 month, the ulcer size was reduced by 96.00 ±1.74% in these patients. The reduction in the ulcer area based on the month analyzed was significant ( = 0.001; < 0.01). After the ulcers healed, the patients were followed for recurrence for one year. Recurrent ulcers were observed at the treated sites in 3 of 31 patients (9%). No adverse events, such as infection, inflammation, or tissue reactions, were observed.

CONCLUSIONS

Application of cell therapy in venous leg ulcer is currently used exclusively in patients not responding to the standard treatment. Autogenously derived regenerative cell therapy for VLUs can be considered as an additional treatment to primary surgical therapy.