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

NCT04235296 | Unknown Phase 1

• 1 other identifier: CHIN-PLAGH-MP-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• wound healing rate

  Original wound area minus unhealed wound area divided by original wound area

  2 months

Study Arms (2)

control group

ACTIVE COMPARATOR

epidermal growth factor

Biological: epidermal growth factor

experimental group

EXPERIMENTAL

mesenchymal stem cell conditioned medium-derived pleiotropic factor

Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor

Interventions

epidermal growth factor BIOLOGICAL

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.

control group

mesenchymal stem cell conditioned medium-derived pleiotropic factor BIOLOGICAL

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.

experimental group

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

PLA Central Theater Air Force Hospital

Datong, Shanxi, China

RECRUITING

MeSH Terms

Interventions

Epidermal Growth Factor

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; EGF Family of Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Xiaobing Fu

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meirong Li, doctor

CONTACT

010-66936345; meirong811225@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 21, 2020
• Study Start: November 17, 2019
• Primary Completion: December 30, 2020
• Study Completion: June 30, 2021
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after completion of the clinical trial
• Access Criteria: One year after completion of clinical trials

Locations

CN (1)