Burn WoundsPhase 1/2NCT07530003
HUMSCs Combined With Col I to Third-Degree Burn Wound
A Phase 1/2 study testing HUMSCs combined with bovine type I collagen, bovine type I collagen and Sterile blank dressing / Vaseline gauze in people with Burn Wounds and Third-Degree Burn Wounds, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn Wounds, Third-Degree Burn Wounds
- What is being tested?
- HUMSCs combined with bovine type I collagen, bovine type I collagen and Sterile blank dressing / Vaseline gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wenjie Ren contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan
Wenjie Ren, 13937354075, 13937354075@163.com
Wenjie Ren
About this study
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
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.
- Conditions
- Burn Wounds, Third-Degree Burn Wounds
- Being tested
- HUMSCs combined with bovine type I collagen, bovine type I collagen, Sterile blank dressing / Vaseline gauze
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUMSCs combined with bovine type I collagenCombination 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 collagenBiological
To evaluate the safety and tolerability of bovine type I collagen in the treatment of third-degree burn wounds
Sterile blank dressing / Vaseline gauzeDevice
To evaluate the safety and tolerability of sterile blank dressing / vaseline gauze in the treatment of third-degree burn wounds.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Group | Experimental | Bovine type I collagen sponge + human umbilical cord mesenchymal stem cells (HUMSCs) Receives: Combination Product: HUMSCs combined with bovine type I collagen |
| Collagen Control Group | Active comparator | Bovine type I collagen sponge alone Receives: Biological: bovine type I collagen |
| Placebo Group | Sham comparator | Sterile blank dressing / Vaseline gauze Receives: Device: Sterile blank dressing / Vaseline gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-epithelialization areas
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
Measured: 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
Measured: Up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start6 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenjie Ren, Principal investigator, The First Affiliated Hospital of Xinxiang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530003
- Sponsor's protocol ID
- HCIBW-2026
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07530003
- Acronym / sponsor ID
- HCIBW-2026
- Conditions
- Burn Wounds, Third-Degree Burn Wounds
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 6 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Experimental | Combination Product: HUMSCs combined with bovine type I collagenBovine type I collagen sponge + human umbilical cord mesenchymal stem cells (HUMSCs) |
| Collagen Control Group | Active comparator | Biological: bovine type I collagenBovine type I collagen sponge alone |
| Placebo Group | Sham comparator | Device: Sterile blank dressing / Vaseline gauzeSterile blank dressing / Vaseline gauze |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUMSCs combined with bovine type I collagenTo 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 | Combination product | Combination Therapy Group |
| bovine type I collagenTo evaluate the safety and tolerability of bovine type I collagen in the treatment of third-degree burn wounds | Biological | Collagen Control Group |
| Sterile blank dressing / Vaseline gauzeTo evaluate the safety and tolerability of sterile blank dressing / vaseline gauze in the treatment of third-degree burn wounds. | Device | Placebo Group |
Primary outcome
Re-epithelialization areas
Time frame: Up to 6 month
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenjie Ren contact
Wenjie Ren principal investigator
The First Affiliated Hospital of Xinxiang Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HUMSCs combined with bovine type I collagen, bovine type I collagen and Sterile blank dressing / Vaseline gauze in people with Burn Wounds and Third-Degree Burn Wounds, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjie Ren (13937354075, 13937354075@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-epithelialization areas (time frame: Up to 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.