Mesenchymal stem cell gel for improving healing of burn skin grafts

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

This study will test whether applying a low- or high-dose mesenchymal stem cell gel to donor skin sites helps them heal faster and with better outcomes after autologous skin grafting in adult burn patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xinxiang Medical College (other)
• Drugs / interventions: radiation
• Locations: 1 site (Xinxiang, Henan)
• Trial ID: NCT07580755 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, parallel-controlled trial enrolling 90 adult burn patients undergoing autologous medium-thick skin grafting. Participants are randomized 1:1:1 to receive a low-dose stem cell gel, a high-dose stem cell gel, or a placebo gel applied to donor/treated skin sites, with 30 patients per group. All groups receive the same surgical and postoperative care and attend regular follow-up visits per protocol. The trial is conducted at a single center and focuses on wound healing outcomes after graft harvest and transplantation.

Who should consider this trial

Good fit: Adults aged 18–65 with burn injuries needing autologous medium-thick skin grafts (donor area lateral thigh or trunk), with total burn area under 30% TBSA and an excised flap area ≥90 cm2, who can consent and comply with follow-up.

Not a fit: Patients with electric, chemical, or radiation burns or other major trauma, those allergic to the gel component (sodium alginate), pregnant or breastfeeding people, or those with severe systemic disease or uncontrolled hypertension/diabetes are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the stem cell gel could speed healing of graft sites, reduce complications, and improve cosmetic and functional outcomes for burn patients.

How similar studies have performed: Similar approaches using mesenchymal stem cells or cell-based dressings have shown promising results in preclinical studies and small clinical series, but robust randomized evidence is still limited.

Eligibility criteria

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.

Where this trial is running

Xinxiang, Henan

• The First Affiliated Hospital of Xinxiang Medical College — Xinxiang, Henan, China (RECRUITING)

Study contacts

• Study coordinator: Wenjie Ren

Conditions: Burn Injury, Burn Patients