Umbilical Cord Mesenchymal Stem Cells for the Repair of Large Area Burn Wounds
Clinical Study on Umbilical Cord Mesenchymal Stem Cells for Wound Repair in Large Area Burn Patients
1 other identifier
interventional
20
1 country
1
Brief Summary
This study intends to adopt a prospective, open, and randomized controlled research method to explore the effectiveness and safety of using human umbilical cord mesenchymal stem cells to treat large-scale burn wounds, in order to break through the limitations of various current treatment methods, explore new clinical treatment methods, promote the repair and healing of skin lesions, and further improve the cure rate and quality of life of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 8, 2023
CompletedStudy Start
First participant enrolled
December 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2028
November 8, 2023
October 1, 2023
4.9 years
November 2, 2023
November 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing rate
(Total area of wound in the operating area - area of unhealed wound)/Total area of wound in the operating area × 100%
On the 21st and 28th days after surgery
Study Arms (4)
Stem cell preparation combined with Reticular skin
EXPERIMENTALStem cell preparation combined with MEEK skin
EXPERIMENTALStem cell preparation combined with split-thickness skin
EXPERIMENTALautologous skin grafting
PLACEBO COMPARATORInterventions
The dose of transplanted stem cells per wound (100cm2) is 1×10\^6, then cover the wound with autologous regular skin.
The dose of transplanted stem cells per wound (100cm2) is 1 × 10 \^ 6, then cover the wound with autologous MEEK skin.
The dose of transplanted stem cells per wound (100cm2) is 1 × 10 \^ 6, then cover the wound with autologous split-thickness skin.
After cleaning the wound, use autologous skin (Reticular skin/MEEK skin/split-thickness skin) grafting and cover the wound surface。
Eligibility Criteria
You may qualify if:
- Selected patients are voluntary and sign an "informed consent form";
- Burn wound area ≥ 20% TBSA, and III ° wound area ≥ 2% TBSA;
- Age range from 18 to 65 years old, regardless of gender;
- Plan to perform two or more limb III degree wounds with scab cutting and autologous skin grafting surgery for treatment;
- No severe heart, lung, blood system, or nervous system diseases;
- There are no clear complications such as systemic infections.
You may not qualify if:
- Patients who do not agree to participate in this experimental study;
- Age\<18 years old or\>65 years old;
- Patients with definite malignant tumors, AIDS, diabetes, and autoimmune diseases;
- Pregnant or lactating patients;
- Individuals with systemic dysfunction;
- Patients with acute and chronic liver and kidney diseases;
- Poor compliance makes it difficult to complete the experiment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ShiCang Yulead
Study Sites (1)
Southwest Hospital, Army Medical University (Third Military Medical University)
Chongqing, Chongqing Municipality, 400038, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 2, 2023
First Posted
November 8, 2023
Study Start
December 20, 2023
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
October 30, 2028
Last Updated
November 8, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share