Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites

NCT04234750 | Unknown Phase 1

• 1 other identifier: MP-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Skin grafting is a standard treatment for deep wounds, but care of the donor site after transplantation is very important. The means of accelerating wound healing can increase overall patient satisfaction. In recent years, cytokine therapy has been an important strategy to promote tissue repair.Mesenchymal stem cells (MSC) have been considered the star cells that promote tissue repair. It works mainly through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1, and hepatocyte growth factor (HGF), have been found and reported in various MSC conditioned media (MSC-CM), And play a role in promoting tissue repair and regeneration. In here, we aim to explore the MSC-CM-derived pleiotropic factor in treating donor sites and further evaluate its safety and effectiveness

Conditions

Evaluate the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Donor Sites

Outcome Measures

Primary Outcomes (1)

• wound healing rate

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

  1 month

Secondary Outcomes (1)

• Vancouver score

  6 months

Study Arms (2)

control group

NO INTERVENTION

no intervention

experimental group

EXPERIMENTAL

mesenchymal stem cell conditioned medium-derived pleiotropic factor

Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor

Interventions

mesenchymal stem cell conditioned medium-derived pleiotropic factor BIOLOGICAL

After the patient is enrolled, when the patient's condition is stable, he is ready to undergo skin transplantation. For the donor site, an electric dermatome was used to remove the skin. The two donor areas of the same patient were divided into a pleiotropic factor group and a blank group randomly. After placing a coarse mesh vaseline oil gauze, then cover a certain thickness of sterile gauze and pressure bandage.

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:

• Mainly mild to moderate burns, III ° burn area is less than 20% (trauma factor is thermal burn); Thick-thickness skin (thickness 0.2-0.3mm), donor area and medium-thickness skin (thick 0.3-0.5mm) for the skin area study separately; Psychologically stable and able to complete the test process-

You may not qualify if:

• History of clotting disorders, uncontrolled diabetes; Drug abuse, excessive drinking, malignant or autoimmune diseases, chemotherapy and immunosuppressive therapy; Significant local infection or combined systemic infection; Patients with severe heart, lung, liver, kidney, blood system and mental and nervous system diseases; Women during pregnancy and lactation-

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

People's Liberation Army Central Air Force Hospital

Datong, Shanxi, China

RECRUITING

Study Officials

• Xiaobing Fu, doctor

  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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: October 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 clinical trial
• Access Criteria: The way of sharing IPD has not yet been determined

Locations

CN (1)