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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04234750
Recruitment Status : Unknown
Verified May 2020 by Xiaobing Fu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : January 21, 2020
Last Update Posted : May 12, 2020
Information provided by (Responsible Party):
Xiaobing Fu, Chinese PLA General Hospital

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

Condition or disease Intervention/treatment Phase
Evaluate the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Donor Sites Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arm Intervention/treatment
No Intervention: control group
no intervention
Experimental: experimental group
mesenchymal stem cell conditioned medium-derived pleiotropic factor
Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor
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.

Primary Outcome Measures :
  1. wound healing rate [ Time Frame: 1 month ]
    Original wound area minus unhealed wound area divided by original wound area

Secondary Outcome Measures :
  1. Vancouver score [ Time Frame: 6 months ]
    Score according to scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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-

Exclusion Criteria:

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-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04234750

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Contact: Meirong Li, doctor 010-66936345

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China, Shanxi
People's Liberation Army Central Air Force Hospital Recruiting
Datong, Shanxi, China
Contact: Wenlin Fan    13835208690   
Sponsors and Collaborators
Chinese PLA General Hospital
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Principal Investigator: Xiaobing Fu, doctor Chinese PLA General Hospital
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Responsible Party: Xiaobing Fu, Proffessor, Chinese PLA General Hospital Identifier: NCT04234750    
Other Study ID Numbers: MP-02
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Need to contact the researcher and open sharing after the researcher's consent
Supporting Materials: Study Protocol
Time Frame: One year after clinical trial
Access Criteria: The way of sharing IPD has not yet been determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No