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Study aim
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Evaluation of safety and efficacy of autologous transplantation of cultured fibroblast on amniotic membrane (AM, as coverage) for healing of mitten hands
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Design
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A clinical trial, uncontrolled, unblinded and not randomized on 20 patients
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Settings and conduct
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EB patients with mitten hands deformity of who willing to recruit to this study attended to the Hazrat-e-Fateme Hospital, Tehran, Iran, or the Dermatology Clinic of Cell Therapy Center at Royan Institute, Tehran, Iran. When the consent form was accepted and the lab test was confirmed, a small skin biopsy was removed from retro auricle and fibroblast cells were separated and cultured. These cells were seeded on AM and the microbial test was done as evidence to prove the safety.
Under general anesthesia, when the hands adhesion was removed, the autologous fibroblast cultured on AM was transplanted to the both hands and the hands were dressed afterward.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
Both genders, Age: 2-30y, No history of other systemic disease, No history of other cell therapy method, No infection in donor or recipient site.
Exclusion Criteria:
Age less than 2y or more than 30y, History of other systemic disease, History of other cell therapy method, Infection in donor or recipient site positive, Lab tests for contagious viral diseases, Pregnancy or lactating History of malignancy.
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Intervention groups
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Biological: cell transplantation
autologous transplantation of cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hands.
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Main outcome variables
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Evaluation of adverse event after transplantation