Safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for healing of deep second-degree burn wounds

Phase 2

Conditions: 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.
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
T22.2
T24.2
T31.2
T21.2

Registration Number: IRCT20080728001031N36

Lead Sponsor: ATI tech pharmed

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 35

Inclusion Criteria

Age between 18-70 years
Acute second-degree heat burns involving 20-50% of the body surface
Existence of at least three 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 course

Exclusion Criteria

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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o 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.

Secondary Outcome Measures

Name	Time	Method
Duration of wound epithelialization. Timepoint: 3, 7, 10, 14, 21, 28 days after intervention. Method of measurement: Solar calendar.;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.