Burn InjuryNCT07580755
Mesenchymal Stem Cells in the Treatment of Burn Wounds
A study testing low-dose stem cell gel group, high-dose stem cell gel group and with only the gel in people with Burn Injury and Burn Patients, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
Burn patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), and received the same treatment under the same conditions simultaneously. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn Injury, Burn Patients
- What is being tested?
- low-dose stem cell gel group, high-dose stem cell gel group and with only the gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- 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
- Voluntary participation and signing of the informed consent form;
- Burn patients, subjects requiring autologous skin grafting;
- Age 18 to 65 years old, gender not restricted;
- During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment;
- Skin burn area < 30% of total body surface area (TBSA);
- The donor skin area is the first time for donation, and the donor skin area is medium-thick skin (thickness approximately 0.4mm);
- The area of the excised skin flap ≥ 90 cm2;
- Able to cooperate with this study protocol and accept regular postoperative follow-up visits.
Who cannot join
- Those allergic to sodium alginate (gel component);
- Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
- Subjects with severe systemic diseases (judged by the researchers);
- Subjects with uncontrolled hypertension or diabetes (judged by the researchers);
- Pregnant or lactating women;
- Subjects whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the efficacy assessment;
Show all 15Show fewer
- Subjects with acute or chronic kidney diseases, renal failure or serum creatinine level = 1.5 times the upper limit of normal value;
- Subjects with acute or chronic liver diseases, total bilirubin, alanine aminotransferase, aspartate aminotransferase = 2.0 times the upper limit of normal value;
- Subjects with a history of malignant tumors;
- Subjects who have participated in other clinical studies for less than 3 months;
- Subjects with mental disorders and without self-awareness, unable to express clearly;
- Subjects using immunosuppressants and those who have been using corticosteroids for a long time (more than 1 month) (excluding local application);
- Subjects with infectious diseases (any one of the four items positive in the test);
- Subjects with other severe systemic diseases;
- Other subjects that the researchers consider not eligible for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 453000
Wenjie Ren, 13937354075, 13937354075@163.com
Wenjie Ren, 13937354075@163.com
About this study
Official title: A Randomized Controlled Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Extensive Burns
Burn patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), and received the same treatment under the same conditions simultaneously.
Read the detailed description
This study adopted a randomized, double-blind, parallel-controlled research method. It planned to enroll 90 burn patients who underwent autologous thick skin transplantation. These patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), with 30 patients in each group. The three groups of subjects received the same treatment under the same conditions simultaneously.
- Conditions
- Burn Injury, Burn Patients
- Being tested
- low-dose stem cell gel group, high-dose stem cell gel group, with only the gel
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose stem cell gel groupCombination product
Using hydrogels containing low-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
high-dose stem cell gel groupCombination product
Using hydrogels containing or without differenthigh-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
with only the gelOther
Using only hydrogels as wound dressings to promote wound healing in burn patients after thick skin grafting
| Study group | Role | What they receive |
|---|---|---|
| low-dose stem cell gel group | Experimental | The gel was applied as the inner dressing evenly to the wound surface. To ensure a uniform and thick application, the dosage of the gel used in each group was kept consistent. A medical surgical film was used as the outer dressing, and a layer of gauze was wrapped on the outermost layer. The gel dressing was used on the day of the surgery, the 3rd day after the surgery, and the 7th day after the surgery. During each dressing change, the dressing was opened layer by layer and carefully removed, and the residual stem cell gel was washed off with sterile normal saline. Receives: Combination Product: low-dose stem cell gel group |
| high-dose stem cell gel group | Experimental | Not described Receives: Combination Product: high-dose stem cell gel group |
| with only the gel | Placebo comparator | Not described Receives: Other: with only the gel |
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 posted12 May 2026
- Study start27 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 InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580755
- Sponsor's protocol ID
- MSCBW-2022
- Status last verified
- Oct 2025
- First submitted
- 28 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Extensive Burns
- ClinicalTrials.gov ID
- NCT07580755
- Acronym / sponsor ID
- MSCBW-2022
- Conditions
- Burn Injury, Burn Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 May 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.
Burn patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), and received the same treatment under the same conditions simultaneously.
Detailed description
This study adopted a randomized, double-blind, parallel-controlled research method. It planned to enroll 90 burn patients who underwent autologous thick skin transplantation. These patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), with 30 patients in each group. The three groups of subjects received the same treatment under the same conditions simultaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-dose stem cell gel group | Experimental | Combination Product: low-dose stem cell gel groupThe gel was applied as the inner dressing evenly to the wound surface. To ensure a uniform and thick application, the dosage of the gel used in each group was kept consistent. A medical surgical film was used as the outer dressing, and a layer of gauze was wrapped on the outermost layer. The gel dressing was used on the day of the surgery, the 3rd day after the surgery, and the 7th day after the surgery. During each dressing change, the dressing was opened layer by layer and carefully removed, and the residual stem cell gel was washed off with sterile normal saline. |
| high-dose stem cell gel group | Experimental | Combination Product: high-dose stem cell gel group |
| with only the gel | Placebo comparator | Other: with only the gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary participation and signing of the informed consent form;
- Burn patients, subjects requiring autologous skin grafting;
- Age 18 to 65 years old, gender not restricted;
- During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment;
- Skin burn area < 30% of total body surface area (TBSA);
Key exclusion criteria (15 listed)
- Those allergic to sodium alginate (gel component);
- Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
- Subjects with severe systemic diseases (judged by the researchers);
- Subjects with uncontrolled hypertension or diabetes (judged by the researchers);
- Pregnant or lactating women;
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 |
|---|---|---|
| low-dose stem cell gel groupUsing hydrogels containing low-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting | Combination product | low-dose stem cell gel group |
| high-dose stem cell gel groupUsing hydrogels containing or without differenthigh-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting | Combination product | high-dose stem cell gel group |
| with only the gelUsing only hydrogels as wound dressings to promote wound healing in burn patients after thick skin grafting | Other | with only the gel |
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 12 May 2026.
Related trials for Burn Injury
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-dose stem cell gel group, high-dose stem cell gel group and with only the gel in people with Burn Injury and Burn Patients, 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 8 inclusion and 15 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 12 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.
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 12 May 2026.