Recruiting
Not applicable
Mesenchymal Stem Cells in the Treatment of Burn Wounds
Condition(s) studied
Burn InjuryBurn Patients
Investigational drug(s) / intervention(s)
low-dose stem cell gel grouphigh-dose stem cell gel groupwith only the gel
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
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
with only the gel: Using only hydrogels as wound dressings to promote wound healing in burn patients after thick skin grafting
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.
Eligibility
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.
Primary outcome measure(s)
- Re-epithelialization areas — Up to 6 month
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
- Complete burn wound healing — Up to 12 month
Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The First Affiliated Hospital of Xinxiang Medical College |
Xinxiang |
Henan |
Recruiting |
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