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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-17

Study Completion Date

2021-06-30

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

experimental group

mesenchymal stem cell conditioned medium-derived pleiotropic factor

Group Type EXPERIMENTAL

mesenchymal stem cell conditioned medium-derived pleiotropic factor

Intervention Type BIOLOGICAL

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.

Interventions

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mesenchymal stem cell conditioned medium-derived pleiotropic factor

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.

Intervention Type BIOLOGICAL

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-

Minimum Eligible Age

6 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No