Back to resultsMesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound
Primary Purpose
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
epidermal growth factor
mesenchymal stem cell conditioned medium-derived pleiotropic factor
Sponsored by
About this trial
This is an interventional treatment trial for Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound
Eligibility Criteria
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. -
Sites / Locations
- PLA Central Theater Air Force HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
experimental group
Arm Description
epidermal growth factor
mesenchymal stem cell conditioned medium-derived pleiotropic factor
Outcomes
Primary Outcome Measures
wound healing rate
Original wound area minus unhealed wound area divided by original wound area
Secondary Outcome Measures
Full Information
NCT ID
NCT04235296
First Posted
January 17, 2020
Last Updated
May 9, 2020
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04235296
Brief Title
Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound
Official Title
Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 17, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
epidermal growth factor
Arm Title
experimental group
Arm Type
Experimental
Arm Description
mesenchymal stem cell conditioned medium-derived pleiotropic factor
Intervention Type
Biological
Intervention Name(s)
epidermal growth factor
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
mesenchymal stem cell conditioned medium-derived pleiotropic factor
Intervention Description
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.
Primary Outcome Measure Information:
Title
wound healing rate
Description
Original wound area minus unhealed wound area divided by original wound area
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meirong Li, doctor
Phone
010-66936345
Email
meirong811225@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaobing Fu
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
PLA Central Theater Air Force Hospital
City
Datong
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenlin Fan
Phone
13835208690
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound
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