A Phase 1 interventional study of Secretome in Trophic Ulcer, Leprosy and Morbus Hansen, sponsored by Yohanes Firmansyah, dr, MH, MM. Completed at 2 sites in Indonesia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Yohanes Firmansyah, dr, MH, MM · Phase 1, Interventional, and Treatment
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
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
This study's enrollment of 27 is below the median of 70 across 41 interventional studies indexed under Leprosy.
Browse Leprosy studies →Yohanes Firmansyah, dr, MH, MM is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs) made as much as 0.1cc / 1cm intracutaneously with a flexpen device in the wound area every 2 weeks.
Biological: Secretome
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.
Changes in Wound Size - Length
Digital measurements of Length carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm
Time frame: 4 weeks
Changes in Wound Size - Width
Digital measurements of Width carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm
Time frame: 4 weeks
Changes in Wound Size - Area
Digital measurements carried out by multiplying the length and width of the wound over time (1 time per week for 4 weeks) in units of cm squares
Time frame: 4 weeks
Adverse event of Allergic
Assessment of side effects in the form of allergies for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and sought to know about the causal from these side effects
Time frame: 4 weeks
Adverse event of Erythema
Assessment of side effects in the form of erythema for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and searched for causal from these side effects
Time frame: 4 weeks
Adverse event of Angioedema and Urticaria
Assessment of side effects in the form of Angioedema and Urticaria for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and searched for causal from these side effects
Time frame: 4 weeks
Adverse event of Tumor
Assessment of side effects in the form of Tumor for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and searched for causal from these side effects
Time frame: 4 weeks
Plan to share: Undecided
Ran from Jan 2019 to primary completion in Jan 2022, 36 months.
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Yohanes Firmansyah, dr, MH, MM