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

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04235296

Collaborator

(none)

Enrollment

Location

Arms

19.4

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound	Biological: epidermal growth factor Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound

Actual Study Start Date :

Nov 17, 2019

Anticipated Primary Completion Date :

Dec 30, 2020

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group epidermal growth factor	Biological: 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.
Experimental: experimental group mesenchymal stem cell conditioned medium-derived pleiotropic factor	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.

Arm

Intervention/Treatment

Active Comparator: control group

epidermal growth factor

Biological: 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.

Experimental: experimental group

mesenchymal stem cell conditioned medium-derived pleiotropic factor

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.

Outcome Measures

Primary Outcome Measures

wound healing rate [2 months]
Original wound area minus unhealed wound area divided by original wound area

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PLA Central Theater Air Force Hospital	Datong	Shanxi	China

Sponsors and Collaborators

Chinese PLA General Hospital

Investigators

Principal Investigator: Xiaobing Fu, Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaobing Fu, Professor, Chinese PLA General Hospital

ClinicalTrials.gov Identifier:

NCT04235296

Other Study ID Numbers:

CHIN-PLAGH-MP-03

First Posted:

Jan 21, 2020

Last Update Posted:

May 12, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wounds and Injuries

Burns

Mitogens

Study Results

No Results Posted as of May 12, 2020