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.