Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites

Study Overview
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Brief Summary
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Skin grafting is a standard treatment for deep wounds, but care of the donor site after transplantation is very important. The means of accelerating wound healing can increase overall patient satisfaction. In recent years, cytokine therapy has been an important strategy to promote tissue repair.Mesenchymal stem cells (MSC) have been considered the star cells that promote tissue repair. It works mainly through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1, and hepatocyte growth factor (HGF), have been found and reported in various MSC conditioned media (MSC-CM), And play a role in promoting tissue repair and regeneration. In here, we aim to explore the MSC-CM-derived pleiotropic factor in treating donor sites and further evaluate its safety and effectiveness

Official Title
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The Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites

Conditions
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Evaluate the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Donor Sites

Intervention / Treatment
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* Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mainly mild to moderate burns, III ° burn area is less than 20% (trauma factor is thermal burn); Thick-thickness skin (thickness 0.2-0.3mm), donor area and medium-thickness skin (thick 0.3-0.5mm) for the skin area study separately; Psychologically stable and able to complete the test process- Exclusion Criteria: History of clotting disorders, uncontrolled diabetes; Drug abuse, excessive drinking, malignant or autoimmune diseases, chemotherapy and immunosuppressive therapy; Significant local infection or combined systemic infection; Patients with severe heart, lung, liver, kidney, blood system and mental and nervous system diseases; Women during pregnancy and lactation-

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>no intervention | |
| Experimental: experimental group<br>mesenchymal stem cell conditioned medium-derived pleiotropic factor | Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor<br>* After the patient is enrolled, when the patient's condition is stable, he is ready to undergo skin transplantation. For the donor site, an electric dermatome was used to remove the skin. The two donor areas of the same patient were divided into a pleiotropic factor group and a blank group randomly. After placing a coarse mesh vaseline oil gauze, then cover a certain thickness of sterile gauze and pressure bandage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing rate | Original wound area minus unhealed wound area divided by original wound area | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancouver score | Score according to scale | 6 months |