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RecruitingNCT07580755Updated May 12, 2026

Mesenchymal Stem Cells in the Treatment of Burn Wounds

An interventional study of low-dose stem cell gel group and high-dose stem cell gel group in Burn Injury and Burn Patients, sponsored by The First Affiliated Hospital of Xinxiang Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by The First Affiliated Hospital of Xinxiang Medical College · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 24 studies in Burns with a site in China — 10 open to participants now, 11 under way, none of them phase 3. Burns · China.

Planned enrollment
8th of 20
90 · median 67
Started
2026
with 2 others
No phase
12 of 24
6 open now
Primary completion
2027-12
later than 7 of 10 live
Registered
24th of 24
by date
Lead sponsor
2 of 24
The First Affiliated Hospital of Xinxiang Medical College

Among the 24 studies in Burns with a site in China, this one is the 8th largest by planned enrollment of the 20 interventional ones that give a count, is one of 3 that started in 2026, is one of 12 with no phase, reaches primary completion later than 7 of the 10 other live ones, and was the 24th registered.

Burns

906 studies on the registry are indexed under Burns; 165 are open to participants now.

Browse Burns studies →

Open to participants now

10 of the 24 studies in Burns with a site in China are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 84 Burns studies recruiting now, 38 (45%) set no upper age limit and 37 (44%) stop at 75 or younger; 17 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Burns with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Burn Injury
  • Burn Patients

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntary participation and signing of the form;
  2. Burn patients, subjects requiring autologous skin grafting;
  3. Age 18 to 65 years old, gender not restricted;
  4. During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment;
  5. Skin burn area \< 30% of total body surface area (TBSA);
  6. The donor skin area is the first time for donation, and the donor skin area is medium-thick skin (thickness approximately 0.4mm);
  7. The area of the excised skin flap ≥ 90 cm2;
  8. Able to cooperate with this study protocol and accept regular postoperative follow-up visits.

Exclusion criteria

Exclusion Criteria:

  1. Those allergic to sodium alginate (gel component);
  2. Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
  3. Subjects with severe systemic diseases (judged by the researchers);
  4. Subjects with uncontrolled hypertension or diabetes (judged by the researchers);
  5. Pregnant or lactating women;
  6. Subjects whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the efficacy assessment;
  7. Subjects with acute or chronic kidney diseases, renal failure or serum creatinine level = 1.5 times the value;
  8. Subjects with acute or chronic liver diseases, total , , aspartate aminotransferase = 2.0 times the upper limit of normal value;
  9. Subjects with a history of malignant tumors;
  10. Subjects who have participated in other clinical studies for less than 3 months;
  11. Subjects with mental disorders and without self-awareness, unable to express clearly;
  12. Subjects using and those who have been using for a long time (more than 1 month) (excluding local application);
  13. Subjects with infectious diseases (any one of the four items positive in the test);
  14. Subjects with other severe systemic diseases;
  15. Other subjects that the researchers consider not eligible for inclusion.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    low-dose stem cell gel group

    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.

    Combination Product: low-dose stem cell gel group

  • Experimental
    high-dose stem cell gel group

    Combination Product: high-dose stem cell gel group

  • Placebo comparator
    with only the gel

    Other: with only the gel

Interventions

  • Combination productlow-dose stem cell gel group

    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

  • 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

  • Otherwith only the gel

    Using only hydrogels as wound dressings to promote wound healing in burn patients after thick skin grafting

06

What researchers measure

Primary outcomes

  1. Re-epithelialization areas

    Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs

    Time frame: Up to 6 month

  2. Complete burn wound healing

    Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs

    Time frame: Up to 12 month

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Dec 2027, 20 months later.

Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 20 months is above that.

Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2026
First posted
May 12, 2026
StartEst.
Apr 27, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2028
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07580755
Lead sponsor
The First Affiliated Hospital of Xinxiang Medical College
Responsible party
Sponsor
First posted
May 12, 2026
Start date
Apr 27, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 12, 2026

Study contacts

Wenjie Ren
Contact
13937354075@163.com
13937354075

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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