Human umbilical cord mesenchymal stem cells with bovine type I collagen for third-degree burn wounds
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Exploratory Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Combined With Bovine Type I Collagen for Promoting Third-Degree Burn Wound Repair
Run by The First Affiliated Hospital of Xinxiang Medical College · NCT07530003 · Data updated 2026-11-12
This will test whether human umbilical cord mesenchymal stem cells combined with bovine type I collagen are safe and tolerable for adults with small third-degree burn wounds.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | The First Affiliated Hospital of Xinxiang Medical College Academic / other |
| Locations | 1 site (Xinxiang, Henan) |
| Status | Recruiting |
| Started | April 6, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07530003 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with confirmed third‑degree burns covering 1–5% TBSA who can be admitted within 72 hours and complete follow‑up are ideal candidates.
✕Probably not a fit
Patients who are pregnant or lactating, have severe immunodeficiency or organ failure, uncontrolled wound infection, hypersensitivity to collagen or stem cell components, or burns outside the 1–5% TBSA window are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1/2 interventional trial gives adults with 1–5% total body surface area third‑degree burns a topical treatment of human umbilical cord mesenchymal stem cells combined with bovine type I collagen, with comparison arms receiving collagen alone or standard sterile/Vaseline gauze dressing. Eligible participants are 18–65 years old and must be admitted within 72 hours of the burn. The primary focus is on safety and tolerability, with monitoring for adverse events, local reactions, and wound complications during follow-up. The study will also observe wound healing progress and signs of improved tissue repair.
Why it matters
Potential benefit: If successful, the approach could speed healing and reduce scarring for small-area third-degree burns.
How similar studies have gone: Preclinical work and early-phase clinical reports of mesenchymal stem cells and collagen scaffolds for wound repair have shown promise, but larger randomized studies are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18-65 years, gender unrestricted * Confirmed third-degree burns, wound area 1%-5% TBSA * Admission within 72 hours after burn injury * Voluntarily signed informed consent * Able to cooperate and complete follow-up Exclusion Criteria: * 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
Where it's running
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The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China Recruiting
Study contacts
- Principal investigator: Wenjie Ren — The First Affiliated Hospital of Xinxiang Medical College
- Study coordinator: Wenjie Ren
- Email: 13937354075@163.com
- Phone: 13937354075
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study will test whether showing 3D hologram images during dressing changes can reduce pain, anxiety, and fear in children ages 3 to 12 with small second-degree burns.
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Field Shield wound dressing for partial-thickness (second-degree) burns
This trial tests whether the Field Shield Wound Dressing heals second-degree burn wounds faster and with less pain and infection than a standard silver dressing.
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KJ101 for debridement of deep second-degree burns
This trial will test whether topical KJ101 helps remove dead tissue and promote healing in adults with deep second-degree burns compared with chymotrypsin and placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.