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Recruiting NCT07530003

HUMSCs Combined With Col I to Third-Degree Burn Wound

Phase I / Phase II Interventional Burn Wounds Third-Degree Burn Wounds

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HUMSCs combined with bovine type I collagen, bovine type I collagen, Sterile blank dressing / Vaseline gauze.
Who it may be relevant to
Registry conditions: Burn Wounds, Third-Degree Burn Wounds. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen in the treatment of third-degree burn wounds.

Interventions

  • Combination product HUMSCs combined with bovine type I collagen
    To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen in the treatment of third-degree burn wounds
  • Biological bovine type I collagen
    To evaluate the safety and tolerability of bovine type I collagen in the treatment of third-degree burn wounds
  • Device Sterile blank dressing / Vaseline gauze
    To evaluate the safety and tolerability of sterile blank dressing / vaseline gauze in the treatment of third-degree burn wounds.

Primary outcome measures

  • Re-epithelialization areas [Time frame: Up to 6 month]
  • Complete burn wound healing [Time frame: Up to 12 month]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Xinxiang Medical College — Xinxiang

Identifiers

NCT: NCT07530003 · HCIBW-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗