Efficacy of Cultured Allogenic Keratinocytes in Treatment of Deep Second-Degree Burn

Abstract

Introduction Cultured allogenic keratinocytes, produced as Kaloderm® (Tego Science, Seoul, Korea) is an effective dressing material for burn wounds. Generally, deep second-degree contact, steam and flame burns tend to progress to third-degree burns. This study reviews the efficacy of cultured allogenic keratinocytes in deep-second degree burn patients. Methods This is a retrospective study of 64 patients treated between November 2013 and April 2019. Half of deep second-degree contact, steam and flame burn patients were treated with cultured allogenic keratinocytes. The other half were treated with chlorhexidine gauze and antibiotic ointment. The primary outcome was time to wound closure. A secondary outcome was number of Kaloderm sheets used. Groups were compared based on type of burn and treatment. Results In the experimental group, the median times to reepithelization were 10.0 days for the contact burn group, 13.5 days for the flame burn group and 11.0 days for the steam burn group. Progression to a third-degree burn occurred in only one patient in the experimental group and four patients in the control group. Patients treated with cultured allogenic keratinocytes required a mean time of 11.7±2.4 days for complete closure, whereas the mean time to complete closure in the control group was 16.4±5.3 days. Conclusion Patients with deep second degree burns from flame, steam, and contact treated with cultured allogenic keratinocytes re-epithelialized faster than those treated with chlorhexidine dressings.

A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial

“…In addition, these skin substitutes have some advantages in comparison with the surgical skin grafts, such as lower infection rate, faster healing process, and less scar tissue [ 23 , 24 ]. Keratinocyte sheets are one of the skin substitutes that their safety and efficacy have been reported by previous studies [ 25 , 26 ]. For instance, Kim et al investigated the effectiveness of the keratinocyte sheet (Kaloderm®) in deep second-degree burn wounds and compared outcomes with standard treatments (chlorhexidine gauze and antibiotic ointment) as control [ 26 ].…”

“…Keratinocyte sheets are one of the skin substitutes that their safety and efficacy have been reported by previous studies [ 25 , 26 ]. For instance, Kim et al investigated the effectiveness of the keratinocyte sheet (Kaloderm®) in deep second-degree burn wounds and compared outcomes with standard treatments (chlorhexidine gauze and antibiotic ointment) as control [ 26 ].…”

The use of human‐derived feeder layers for the cultivation of transplantable human epidermal cell sheet to repair second degree burn wounds

“…[10][11][12] In Korea, cryopreserved allo-ECS product (Kaloderm, Tego Science) was approved and became available as a public health insurance benefit for burn wound treatment. 13,14 However, using of animal-derived feeder layer manufacture allo-ECS can increase risk to deliver animal-borne infection. Alternative use of animal-derived components for manufacturing of cell-based medicinal products has encouraged by different countries.…”

“…Allo‐ECS are most used in the wound care centre to stimulate the healing of donor sites and treat partial thickness defect wound 10–12 . In Korea, cryopreserved allo‐ECS product (Kaloderm, Tego Science) was approved and became available as a public health insurance benefit for burn wound treatment 13,14 …”

Dried human-cultured epidermis accelerates wound healing in a porcine partial-thickness skin defect model

“…Also, allo-CE is usually cryopreserved and stored in hospitals to keep it available for patients. For instance, a cryopreserved allogeneic CE, Kaloderm® (Tego Science, Seoul, Korea), is available in Korea for treating dermal burns and diabetic foot ulcers [ 10 ]. However, the need for long-term preservation without changing the product quality and freezers during the storage and transportation of cryopreserved products represents a problem in clinics.…”