At a glance
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Effectiveness of Giving Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)
In Brief
A Phase 1 clinical trial evaluating Secretome for Trophic Ulcer and 2 related conditions. Completed, enrolled 27 participants across 2 sites.
Detailed Summary
Background: Trophic ulcer is one of the complications that arise due to leprosy infection of the skin and includes diseases that trigger permanent disability and reduce the quality of life of the person. The facts in the field that more than 50% of chronic ulcers, especially trophic ulcers due to leprosy fail to heal with usual treatment. Therefore it is important to do a new method in healing trophic ulcers. Stem cell therapy or one of them is conditioned medium mesenchymal stem cell is a promising therapy because of its biological and physiological processes resembling the mechanism of wound healing Method: This research is a clinical trial research "Open Trial". Phase 1 to see the side effects caused by the intervention. Minimum sample size of 20 respondents with trophic ulcers due to leprosy that is difficult to resolve with usual treatment. The main outcome is wound healing in terms of the length and extent of the wound. The secondary outcome is treatment toxicity 4 weeks after administration. Follow-up visits will be scheduled at 2, 4, and 12 weeks post-treatment. If the results confirm safety, feasibility and potential efficacy, large multicenter randomized controlled trials with longer follow-up will begin with a focus on the effectiveness of therapy
Study Details
Timeline
Interventions
The interventions given in this study were Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs) as much as 0.1cc / 1cm intracutaneously with a flexpen device in the wound area every 2 weeks. The variables in this study were divided into two, namely the independent variable was the use of Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs) were administered intracutaneously, and the dependent variables were wound healing and side effects caused by the interventions given. Wound healing or repair in this study was assessed from several variables, namely the presence of granulation tissue growth, reduced edema, reduced erythema and improvement in wound size both in terms of length, width, and area measured by using a standard ruler and digital photo.