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

NCT ID: NCT04235296

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-17

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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control group

epidermal growth factor

Group Type ACTIVE_COMPARATOR

epidermal growth factor

Intervention Type 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.

experimental group

mesenchymal stem cell conditioned medium-derived pleiotropic factor

Group Type EXPERIMENTAL

mesenchymal stem cell conditioned medium-derived pleiotropic factor

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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. -
Minimum Eligible Age

6 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaobing Fu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaobing Fu

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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PLA Central Theater Air Force Hospital

Datong, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Meirong Li, doctor

Role: CONTACT

010-66936345

Facility Contacts

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Wenlin Fan

Role: primary

13835208690

Other Identifiers

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CHIN-PLAGH-MP-03

Identifier Type: -

Identifier Source: org_study_id

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