HUMSCs Combined With Col I to Third-Degree Burn Wound

April 28, 2026 updated by: The First Affiliated Hospital of Xinxiang Medical College

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wenjie Ren

Study Locations

  • China
    • Henan
      • Xinxiang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical College
        • Contact:
        • Contact:
          • Wenjie Ren

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination Therapy Group
Bovine type I collagen sponge + human umbilical cord mesenchymal stem cells (HUMSCs)
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
Active Comparator: Collagen Control Group
Bovine type I collagen sponge alone
Biological: bovine type I collagen
To evaluate the safety and tolerability of bovine type I collagen in the treatment of third-degree burn wounds
Sham Comparator: Placebo Group
Sterile blank dressing / Vaseline gauze
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-epithelialization areas
Time Frame: Up to 6 month
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
Up to 6 month
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
Up to 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Investigators

  • Principal Investigator: Wenjie Ren, The First Affiliated Hospital of Xinxiang Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 6, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCIBW-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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