Clinical trial NCT05777213: Potential Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)
Official title: Effectiveness of Giving Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CM-MSC ; Stem Cell ; Trophic Ulcer ; Leprosy ; Morbun Hansen; Secretom
Lead sponsor: Tarumanagara University
Sponsor class: OTHER
Collaborators: name: Tarumanagara University
First posted: 2023-03-21
Enrollment: 27
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Wound Size - Length
timeFrame: 4 weeks
measure: Changes in Wound Size - Width
timeFrame: 4 weeks
measure: Changes in Wound Size - Area
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: Adverse event of Allergic
timeFrame: 4 weeks
measure: Adverse event of Erythema
timeFrame: 4 weeks
measure: Adverse event of Angioedema and Urticaria
timeFrame: 4 weeks
measure: Adverse event of Tumor
timeFrame: 4 weeks
Locations:
city: Tangerang
country: Indonesia
facility: Sukma Clinic
state: Banten
city: Singkawang
country: Indonesia
facility: RS Alverno Singkawang
state: West Borneo
Study officials:
References:
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