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

Phase 2

Not yet recruiting

• 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

Study Timeline

• Last Update Posted: 2024-05-27

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