Actively Recruiting
A Randomized Controlled Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Extensive Burns
Led by The First Affiliated Hospital of Xinxiang Medical College · Updated on 2026-05-12
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the use of mesenchymal stem cells derived from the placenta to treat burn wounds in patients aged 18 to 65 years who require autologous thick skin transplantation. Researchers aim to compare low-dose and high-dose stem cell gel treatments against a placebo gel to assess their effects on wound healing. This randomized, double-blind, parallel-controlled study enrolls 90 burn patients divided equally into three groups to ensure consistent treatment conditions. Participants receive wound dressings made from hydrogels containing different doses of stem cells or only the gel as a placebo. The gel is applied evenly as an inner dressing on the burn wound surface immediately after surgery and again on the 3rd and 7th days post-surgery. The dressings are layered with a medical surgical film and gauze, which are carefully removed during each dressing change, and residual gel is washed off with sterile normal saline. During the study, participants undergo regular postoperative follow-up visits to monitor healing progress. Researchers assess the re-epithelialization areas for up to 6 months and complete burn wound healing for up to 12 months. The study tracks wound recovery and safety over this period, ensuring participants adhere to the protocol and receive consistent care throughout the trial duration.
CONDITIONS
Brief Title
Mesenchymal Stem Cells in the Treatment of Burn Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation and signing of the informed consent form
- Burn patients requiring autologous thick skin grafting
- Age between 18 and 65 years, any gender
- Treatment with a single donor skin area (lateral thigh or trunk)
- Skin burn area less than 30% of total body surface area
- First-time donor skin area with medium-thick skin (~0.4mm thickness)
- Excised skin flap area of at least 90 cm2
- Ability to cooperate with the study protocol and attend regular postoperative follow-up visits
You will not qualify if you...
- Allergy to sodium alginate (gel component)
- Electric shock injuries, chemical burns, radiation injuries, or combined traumas
- Severe systemic diseases as judged by researchers
- Uncontrolled hypertension or diabetes
- Pregnant or lactating women
- Conditions affecting study assessment or requiring treatments that may affect efficacy evaluation
- Acute or chronic kidney diseases, renal failure, or elevated serum creatinine
- Acute or chronic liver diseases or elevated liver enzymes
- History of malignant tumors
- Participation in other clinical studies within the last 3 months
- Mental disorders with lack of self-awareness or inability to communicate clearly
- Use of immunosuppressants or long-term corticosteroids (over 1 month), excluding local application
- Infectious diseases with positive test results
- Other severe systemic diseases
- Any other conditions deemed unsuitable by the researchers
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 - Treatment dressing applied on the day of surgery, and on the 3rd and 7th days after surgery
Participants receive wound dressings containing different doses of placenta-derived mesenchymal stem cells or only the gel after autologous thick skin grafting to promote burn wound healing.
3 dressing change visits
Duration - Up to 12 months
Participants attend regular postoperative visits to assess wound healing and recovery up to 12 months after treatment.
Regular follow-up visits for wound healing assessments
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China, 453000
Actively Recruiting
Research Team
W
Wenjie Ren
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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