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

Phase 1
Conditions
Evaluate the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Donor Sites
Interventions
Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor
Registration Number
NCT04234750
Lead Sponsor
Chinese PLA General Hospital
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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
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-

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
experimental groupmesenchymal stem cell conditioned medium-derived pleiotropic factormesenchymal stem cell conditioned medium-derived pleiotropic factor
Primary Outcome Measures
NameTimeMethod
wound healing rate1 month

Original wound area minus unhealed wound area divided by original wound area

Secondary Outcome Measures
NameTimeMethod
Vancouver score6 months

Score according to scale

Trial Locations

Locations (1)

People's Liberation Army Central Air Force Hospital

🇨🇳

Datong, Shanxi, China

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