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
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2026
CompletedFirst Submitted
Initial submission to the registry
April 8, 2026
CompletedFirst Posted
Study publicly available on registry
April 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
May 4, 2026
April 1, 2026
1.7 years
April 8, 2026
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Re-epithelialization areas
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
Up to 6 month
Complete burn wound healing
Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs
Up to 12 month
Study Arms (3)
Combination Therapy Group
EXPERIMENTALBovine type I collagen sponge + human umbilical cord mesenchymal stem cells (HUMSCs)
Collagen Control Group
ACTIVE COMPARATORBovine type I collagen sponge alone
Placebo Group
SHAM COMPARATORSterile blank dressing / Vaseline gauze
Interventions
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
To evaluate the safety and tolerability of bovine type I collagen in the treatment of third-degree burn wounds
To evaluate the safety and tolerability of sterile blank dressing / vaseline gauze in the treatment of third-degree burn wounds.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenjie Ren
The First Affiliated Hospital of Xinxiang Medical College
Central Study Contacts
Wenjie Ren
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2026
First Posted
April 14, 2026
Study Start
April 6, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share