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

Phase 1

• Conditions: Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound
• Interventions: Biological: epidermal growth factor; Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor

• Registration Number: NCT04235296
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-17
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-21
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12
• Primary Completion: 2020-12-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	epidermal growth factor	epidermal growth factor
experimental group	mesenchymal stem cell conditioned medium-derived pleiotropic factor	mesenchymal stem cell conditioned medium-derived pleiotropic factor

Primary Outcome Measures

Name	Time	Method
wound healing rate	2 months	Original wound area minus unhealed wound area divided by original wound area

Trial Locations

Locations (1)

PLA Central Theater Air Force Hospital; 🇨🇳 Datong, Shanxi, China