Evaluate the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Donor Sites
Conditions
Brief summary
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
Interventions
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.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 60 Years
Healthy volunteers
No
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-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound healing rate | 1 month | Original wound area minus unhealed wound area divided by original wound area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vancouver score | 6 months | Score according to scale |
Countries
China
Contacts
Primary ContactMeirong Li, doctor
Outcome results
None listed