Actively Recruiting
Human Umbilical Cord Mesenchymal Stem Cells Combined With Bovine Type I Collagen for Repairing Third-Degree Burn Wounds: A Randomized, Double-Blind, Placebo-Controlled Clinical Study
Led by The First Affiliated Hospital of Xinxiang Medical College · Updated on 2026-05-04
108
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen for treating third-degree burn wounds. This study is designed as a single-center, randomized, double-blind, placebo-controlled exploratory clinical trial involving adults aged 18 to 65 years with confirmed third-degree burns. The trial aims to assess wound healing and tissue repair over a period extending up to 12 months. Participants will be randomly assigned to one of three groups: a combination therapy group receiving human umbilical cord mesenchymal stem cells with bovine type I collagen, a control group receiving bovine type I collagen alone, or a placebo group treated with sterile blank dressing or Vaseline gauze. Treatments are applied to the burn wounds, and the study will monitor the safety and tolerability of these interventions. Throughout the study, participants will be followed for wound healing progress, with primary outcomes including the area of re-epithelialization up to 6 months and complete burn wound healing up to 12 months. Researchers will perform assessments at regular intervals to monitor healing and safety. Participants are expected to cooperate and complete follow-up visits to support comprehensive evaluation of treatment effects and tolerability.
CONDITIONS
Brief Title
HUMSCs Combined With Col I to Third-Degree Burn Wound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-65 years, gender unrestricted
- Confirmed third-degree burns with wound area of 1%-5% total body surface area (TBSA)
- Admission to hospital within 72 hours after burn injury
- Voluntarily signed informed consent
- Able to cooperate and complete follow-up visits
You will not qualify if you...
- Pregnant or lactating females
- Severe immunodeficiency or autoimmune disease
- History of malignant tumor or coagulation dysfunction
- Severe cardiac, hepatic, or renal insufficiency
- Hypersensitivity to collagen or stem cell components
- Uncontrollable severe wound infection
- Participation in other clinical studies within the past 3 months
- Inability to comply with follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive one of three treatments: a combination of bovine type I collagen sponge and human umbilical cord mesenchymal stem cells, bovine type I collagen sponge alone, or sterile blank dressing / vaseline gauze to treat third-degree burn wounds.
Multiple visits for treatment application and monitoring
Duration - Up to 12 months
Participants are monitored for wound healing and safety after treatment completion.
Regular follow-up visits during the 12-month period
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
Actively Recruiting
Research Team
W
Wenjie Ren
W
Wenjie Ren
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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