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RECRUITING

NCT07580755

Mesenchymal Stem Cells in the Treatment of Burn Wounds

Sponsor: The First Affiliated Hospital of Xinxiang Medical College

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Extensive Burns

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-27

Completion Date

2028-12-31

Last Updated

2026-05-12

Healthy Volunteers

Conditions

Burn Injury Burn Patients

Interventions

COMBINATION_PRODUCT

low-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

COMBINATION_PRODUCT

high-dose stem cell gel group

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

OTHER

with only the gel

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

Inclusion Criteria: 1. Voluntary participation and signing of the informed consent 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: 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 upper limit of normal value; 8. Subjects with acute or chronic liver diseases, total bilirubin, alanine aminotransferase, 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 immunosuppressants and those who have been using corticosteroids 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.

Locations (1)

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, China