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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Datong, Shanxi, China
      • Recruiting
      • PLA Central Theater Air Force Hospital
      • Contact: Wenlin Fan; Phone Number: 13835208690

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: control group; epidermal growth factor	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.
EXPERIMENTAL: experimental group; mesenchymal stem cell conditioned medium-derived pleiotropic factor	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing rate	Original wound area minus unhealed wound area divided by original wound area	2 months

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2019
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (ACTUAL): January 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Burns; Wounds and Injuries; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: CHIN-PLAGH-MP-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Need to contact the researcher and open sharing after the researcher's consent
• IPD Sharing Time Frame: One year after completion of the clinical trial
• IPD Sharing Access Criteria: One year after completion of clinical trials
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No