Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 1

Conditions: Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound

Treatments: Biological: epidermal growth factor; Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor

Study type: Interventional

Funder types: Other

Identifiers

NCT04235296

CHIN-PLAGH-MP-03

Details and patient eligibility

About

Treatment of extensive deep burn residual wounds is a common problem in burn plastic surgery. Due to bacterial invasion, excessive maturation of granulation tissue, poor abrasion resistance of new epithelium, and coexistence of wound healing and dissolution can lead to delayed wound healing. Residual wounds rarely heal spontaneously and are prone to recurrence. Mesenchymal stem cells (MSC) boost tissue repair through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1 have been found in MSC conditioned media (MSC-CM), and play a role in promoting tissue repair and regeneration.Our previous animal experiments have confirmed the role of MSC-CM in regulating wound inflammation, repairing damaged repair cells and promoting wound regeneration. In here, we will evaluate the safety and effectiveness of mesenchymal stem cell conditioned medium-derived pleiotropic factor in treating residual burn wound.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with thermal burns are all residual wounds that have not healed after 1 month; The distance between adjacent residual wounds of the same patient is greater than 10cm; Patients signing informed consent -

Exclusion criteria

Patients with severe heart, lung, liver, kidney, blood and mental system diseases; Combined with diabetes, hypertension and malnutrition; Patients with shock, severe systemic infections, and pregnant or lactating women. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

control group

Active Comparator group

Description:

epidermal growth factor

Treatment:

Biological: epidermal growth factor

experimental group

Experimental group

Description:

mesenchymal stem cell conditioned medium-derived pleiotropic factor

Treatment:

Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor