HUMSCs Combined With Col I to Third-Degree Burn Wound

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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07530003

Enrollment

108

Registered

2026-04-14

Start date

2026-04-06

Completion date

2028-12-31

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Wounds, Third-Degree Burn Wounds

Brief summary

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_PRODUCTHUMSCs 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

BIOLOGICALbovine type I collagen

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

DEVICESterile blank dressing / Vaseline gauze

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Re-epithelialization areas	Up to 6 month	Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
Complete burn wound healing	Up to 12 month	Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs

Countries

China

Contacts

CONTACTWenjie Ren

13937354075@163.com13937354075

PRINCIPAL_INVESTIGATORWenjie Ren

The First Affiliated Hospital of Xinxiang Medical College

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026