Potential Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)

Phase 1

Completed

• Conditions: CM-MSC ; Stem Cell ; Trophic Ulcer ; Leprosy ; Morbun Hansen; Secretom
• Interventions: Biological: Secretome

• Registration Number: NCT05777213
• Lead Sponsor: Yohanes Firmansyah, dr, MH, MM

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-02
• Study First Submitted: 2023-02-27
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Chronic ulcers in Morbus Hansen's patients aged 18-80 years
• Not recovering with routine therapy for at least 1 months
• Trophic ulcers degrees 2 and 3
• Willing to take part in the study
• As well as with the respondent's good health to follow this study.

Exclusion Criteria

• Patients who took anticoagulants,
• Patients had hypertension
• Patients had any staging kidney failure
• Patients had a history of blood disorders and pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs)	Secretome	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.

Primary Outcome Measures

Name	Time	Method
Changes in Wound Size - Area	4 weeks	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
Changes in Wound Size - Length	4 weeks	Digital measurements of Length carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm
Changes in Wound Size - Width	4 weeks	Digital measurements of Width carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm

Trial Locations

Locations (2)

Sukma Clinic; 🇮🇩 Tangerang, Banten, Indonesia

RS Alverno Singkawang; 🇮🇩 Singkawang, West Borneo, Indonesia