Effectiveness of Secretome from Human Umbilical Cord Mesenchymal Stem Cells in Gel (10% SM-hUCMSC Gel) for Chronic Wounds (Diabetic and Trophic Ulcer) – Phase 2 Clinical Trial

BACKGROUND: Chronic wounds carry financial burdens and increase morbidity and mortality, especially in diabetic ulcers and Hansen’s Morbus. More than 50% of chronic ulcers are difficult to heal with regular treatment and require new types of therapy such as the use of secretome of human umbilical cord mesenchymal stem cells (SM-hUCMSC). METHODS: This experimental study was carried out to see the effectiveness of using SM-hUCMSC in diabetic ulcers and Hansen’s Morbus in four medical facilities (multicentre). The level of active secretion has been measured by default in 10% SM-hUCMSC gel, used as a treatment intervention. The primary outcome is wound healing in terms of the length, width, and extent of the wound. The secondary is the side effects of treatment 2 weeks after administration. Follow-up visits will be scheduled at 1 and 2 weeks post-treatment. RESULTS: Forty-one chronic ulcers successfully followed the study until the end. In patients with chronic ulcers, the mean ulcer length, width, and area were 1.60 (0,50–13,0), 1.3 (0,5–6,0), and 2.21 (0,25–78) cm square, respectively, before interventions and 1 (0–12), 0,8 (0–6,0), and 1 (0–72) square cm after interventions at the second follow-up. The change between the beginning and end of the intervention was significant (p-value <0.05). CONCLUSION: The use of 10% SM-hUCMSC gel topically has been proven effective in accelerating the process of wound healing, especially chronic ulcers with side effects that are not present in this study.