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Study aim
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Determining the safety and effectiveness of allogeneic cultured keratinocyte sheets in the treatment of acute second degree acute burns
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Design
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In this single group, open-label clinical trial study, five patients will be enrolled in regular order according to standard protocols. The first patient will be monitored for one month, and if cell therapy is safe, the next patient will be Entered the study. Again, provided the treatment is safe during this period, the second and then the third patient will enter the study. In the absence of severe and life-threatening complications, subsequent patients will be included in the study.
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Settings and conduct
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Location: Operating room of Shahid Motahari Hospital in Tehran
Preliminary laboratory tests are performed at Royan Research Institute and clinical and paraclinical tests are performed at Shahid Motahari Hospital.
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Participants/Inclusion and exclusion criteria
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Patients aged 18 to 70 years with deep second-degree heat burns involving 25 to 40% of the body surface, if they express written consent to participate in the study and wish to attend regular treatment and follow-up courses, enter the study. Pregnant or breastfeeding patients, with uncontrolled underlying disease, requiring intensive care, or multiple traumas are not included in the study.
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Intervention groups
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Product type: Allogeneic keratinocyte sheet
How to use: Allogeneic keratinocyte sheet transplant size 60cm2
Number of transplantation: 1 or 2 times
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Main outcome variables
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Evaluation of side effects, including short-term and long-term, systemic or local, severe or mild, and related and unrelated side effects of cell therapy at times 3, 7, 10, 14, 21, 28 days, and 3 and 6 months after intervention according to CTCAEV5 criteria