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NCT Number: NCT07530003

HUMSCs Combined With Col I to Third-Degree Burn Wound

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.

Recruiting

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Key information

Conditions

Burn Wounds Burns Third-Degree Burn Wounds Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, China

Location status: Recruiting

Location contact

Wenjie Ren

CONTACT

[email protected]

13937354075

Wenjie Ren

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HUMSCs combined with bovine type I collagen

Combination Product

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

bovine type I collagen

Biological

To evaluate the safety and tolerability of bovine type I collagen in the treatment of third-degree burn wounds

Sterile blank dressing / Vaseline gauze

Device

To evaluate the safety and tolerability of sterile blank dressing / vaseline gauze in the treatment of third-degree burn wounds.

Primary outcomes

  1. Re-epithelialization areas

    Time frame: Up to 6 month

    Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs

  2. Complete burn wound healing

    Time frame: Up to 12 month

    Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjie Ren

CONTACT

[email protected]

13937354075

Wenjie Ren

CONTACT

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xinxiang Medical College

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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