Autogenously derived regenerative cell therapy for venous leg ulcers

Abstract

IntroductionVenous 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 methodsBetween 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.ResultsEighteen ulcers demonstrated complete healing at the 12th month. Thirteen ulcers exhibited serious contraction and epithelialization even though the ulcer was not completely closed. At the 12th 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 (p = 0.001; p < 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.ConclusionsApplication 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.

Evaluation of chronic inflammation in the aetiology of venous insufficiency by investigating cytomegalovirus DNA

“…Venous ulcer is a common vascular pathology affecting 1% of the population, and its prevalence increases with age [15,16]. Superficial, perforating, or deep vein insufficiency are risk factors for venous ulceration.…”

Current and advanced therapies for chronic wound infection

“…Many studies have investigated the efficacy of stem-cell therapies for a variety of wounds, including burns, non-healing ulcers, and critical limb ischemia [90][91][92][93][94][95][96]. A systematic review published in 2020 that investigated the clinical application of stem-cell therapy for the treatment of chronic wounds showed the potential of a variety of stem cells in the restoration of impaired wound healing, both in vitro and in vivo, despite the clinical evidence being very limited.…”

Strategies and challenges in the treatment of chronic venous leg ulcers

“…ADSCs are easy to obtain due to lower morbidity during the harvesting procedure[ 78 , 80 ], can be implanted at the wound site immediately following debridement, and promote a new tissue formation rich in vascular structures and remodeling collagen[ 82 ]. As an additional treatment to primary surgical therapy for CVLUs[ 83 ], one study showed that it does not shorten the venous recovery period but decreases the 1-year recurrence rate[ 83 ]. However, preclinical and observational RCT reports indicate that centrifuged adipose tissue containing progenitor cells is safe and may accelerate healing time in CVLUs and reduce wound pain[ 84 ].…”