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

Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound Clinical Trial

Official title:

Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235296
• Other study ID #: CHIN-PLAGH-MP-03
• Status: Recruiting
• Phase: Phase 1
• Start date: November 17, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2020
• Source: Chinese PLA General Hospital
• Contact: Meirong Li, doctor
• Phone: 010-66936345
• Email: meirong811225[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 60 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Burns
• Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound
• Wounds and Injuries

Intervention

Biological:
• epidermal growth factor
Residual wounds from the same person were divided into control group and experimental group. The epidermal growth factor is used to control group. Then the foam wound dressing was selected to cover the residual wound, and the dressing was changed every 2 days.
• mesenchymal stem cell conditioned medium-derived pleiotropic factor
Residual wounds from the same person were divided into control group and experimental group. The pleiotropic factor is used to control group. Then the foam wound dressing was selected to cover the residual wound, and the dressing was changed every 2 days.

Locations

Country	Name	City	State
China	PLA Central Theater Air Force Hospital	Datong	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing rate	Original wound area minus unhealed wound area divided by original wound area	2 months