NCT07580755 Mesenchymal Stem Cells in the Treatment of Burn Wounds
| NCT ID | NCT07580755 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Xinxiang Medical College |
| Condition | Burn Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-04-27 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07580755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Burn Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07580755 currently recruiting?
Yes, NCT07580755 is actively recruiting participants. Contact the research team at 13937354075@163.com for enrollment information.
Where is the NCT07580755 trial being conducted?
This trial is being conducted at Xinxiang, China.
Who is sponsoring the NCT07580755 clinical trial?
NCT07580755 is sponsored by The First Affiliated Hospital of Xinxiang Medical College. The trial plans to enroll 90 participants.