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IRCT20080728001031N31 IRCT 2022-04-23 ATI tech pharmed Safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for healing of deep second degree burn wounds Safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for healing of deep second degree burn wounds: clinical trial phase I 2022-05-22 anticipated 5 Complete https://irct.ir/trial/62833 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Condition 1: Acute second-degree burn wound on the upper limbs. Condition 2: Acute second degree burn wound in trunk. Condition 3: Acute second-degree burn wound on the lower limbs. Condition 4: Acute second degree burn wound involving 25-40% of body surface. Condition 5: Acute second degree burn wound involving 25-40% of body surface. Intervention group: A deep second-degree burn wound of 60 cm2 in limbs or trunk (except joints, arms, legs, and areas where tendons, blood vessels, or bone tissue are exposed) will be selected. This area will be transplanted with an allogeneic keratinocyte sheet with an area of 60 square centimeters. If the wound does not heal on the tenth day, the transplant will be repeated.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is confidentiality and ethical issues
public Shayan Farzanbakhsh
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Resalat Highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2251 8388 Shayan.farzanb@yahoo.com Royan Institute scientific Ensiyeh Hajizadeh Saffar
Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Resalat Highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2233 9942 hajizadeh.ehs@gmail.com Royan Institute Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 18-70 years Acute second-degree heat burns involving 25-40% of the body surface Existence of at least one deep second-degree burn wound with 60 cm2 in area in the trunk or limbs (except the joints and arms & feet) in which tendons, blood vessels, or bone tissue is not exposed Declaration of written consent to participate in the study and willingness to attend regular treatment and follow-up courses 18 years 70 years Both Chronic uncontrolled underlying disease (vascular disease, diabetes, malnutrition, hypertension, cardiovascular disease) Known underlying psychiatric illness Pregnancy or breastfeeding History of cancer or chemotherapy Infection with viral diseases (HCV, HBV, HIV) History of organ transplantation or blood transfusion History of taking immunosuppressive or cytotoxic drugs during the last 6 months Respiratory injury Requires special care Multiple trauma (fracture, or thoracic, abdominal, or CNS trauma) T22.2 T21.2 T24.2 T31.2 T31.3 Burn of second degree of shoulder and upper limb, except wrist and hand Burn of second degree of trunk Burn of second degree of lower limb, except ankle and foot Burns involving 20-29% of body surface Burns involving 30-39% of body surface Treatment - Other Intervention group: A deep second-degree burn wound of 60 cm2 in limbs or trunk (except joints, arms, legs, and areas where tendons, blood vessels, or bone tissue are exposed) will be selected. This area will be transplanted with an allogeneic keratinocyte sheet with an area of 60 square centimeters. If the wound does not heal on the tenth day, the transplant will be repeated. No observed short-term or long term, systemic or local, severe or mild, and related or unrelated to cell therapy adverse effects. Timepoint: before the intervention, 3, 7, 10, 14, 21, 28 days, 3, and 6 months after the intervention. Method of measurement: CTCAEV5 methods. Duration of wound epithelialization. Timepoint: 3, 7, 10, 14, 21, 28 days after intervention. Method of measurement: Solar calender. Graft take rate. Timepoint: 3, 7, 10, 14, 21, 28 days after intervention. Method of measurement: Physician evaluation. Scar assessment. Timepoint: 3 and 6 months after the intervention. Method of measurement: Based on Patient and Observer Scar Assessment Scale (POSAS) score. Scar assessment. Timepoint: 3 and 6 months after the intervention. Method of measurement: Based on (VSS) Vancouver scar scale score. Wound closure and scar shape. Timepoint: 3, 7, 10, 14, 21, 28 days and 3 and 6 months after the intervention. Method of measurement: Based on 2D photography by Canon powershot S5Is. Skin structure and quality improvement. Timepoint: 6 months after the intervention. Method of measurement: Pathological criteria include H&E staining (hematoxylin and eosin), MT (Masson’s Trichrome), and immunohistochemistry (TGFβ-1,3, collagen 1,3 vimentin, α-SMA). ATI tech pharmed Approved 2022-03-08 Research ethics committees of Royan institute-Academic center for education, culture and research Royan Alley, Eastern Hafez St, Northern Banihashem St, 45 m Ghasem Soleymani Highway Tehran Tehran Iran (Islamic Republic of)