Human umbilical cord mesenchymal stem cells with bovine type I collagen for third-degree burn wounds
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
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 |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xinxiang Medical College Academic / other |
| Locations | 1 site (Xinxiang, Henan) |
| Trial ID | NCT07530003 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Xinxiang, Henan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.