Mesenchymal Stem Cells in the Treatment of Burn Wounds

NCT07580755 | Recruiting DMC

• 1 other identifier: MSCBW-2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burn Injury; Burn Patients

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)

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.

Combination Product: low-dose stem cell gel group

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

Interventions

high-dose stem cell gel group COMBINATION_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

high-dose stem cell gel group

with only the gel OTHER

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

with only the gel

low-dose stem cell gel group COMBINATION_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

low-dose stem cell gel group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, 453000, China

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Wenjie Ren

CONTACT

13937354075; 13937354075@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2025-10

Locations

CN (1)