|
KMID : 0853020070100020112
|
|
Journal of Korean Burn Society
2007 Volume.10 No. 2 p.112 ~ p.117
|
|
|
Clinical Study of Autologous Cultured Keratinocyte Cell Spray "KerahealTM" on Severe Burn Wound
|
|
Ha Tae-Sun
Cho Yong-Suk
Kim Do-Hern
Hur Jun
Chun Wook
Kim Jong-Hyun
Jang Young-Chul
Kim Yun-Young
Son Young-Sook
|
|
|
Abstract
|
|
|
Backgrounds: Cultured epithelial autograft has been available in market for sometime now but not widely applied clinically due to the weaknesses in infection and absence of vascular structures. Many researches are on going around the world to overcome those weaknesses and improve its clinical efficacy. As one of those attempts, KerahealTM was developed by MCTT and it is now provided in suspension type which can simply be sprayed on the wound site rather than applying it as a sheet type. In this study, authors will analyze the clinical efficacy of the new forms of cultured epithelial autograft provided as suspension type in a vial.
Methods: At 4∼6 post burn day, cadaveric allograft skin was applied on the excised wound bed and clean skin biopsy of 1 cm2 was obtained for culturing. At the lab (MCTT), keratinocytes were isolated from the skin biopsy by magnetic cell isolation methods then cultured using serum free medium under the GMP facility for 16 days. User 18∼21 days later, wide meshed autograft (1：5∼6) was applied on the newly formed granulation tissues on wound bed. KerahealTM was simply inoculated using Tissomat cell spray and followed by Tissucol spray. Finally, conventional wet dressing was applied. The take rate of sprayed cells was estimated at 2 and 4 weeks by naked eye examinations of two certified burn surgeons and digital imaging. The status of scar formation was analyzed based on vancouver scar scale at 8, 12 and 24 weeks respectively.
Results: Each of ten patients out of thirteen subject received one treatment of KerahealTM but three were excluded from the study since one patient was deceased after escharectomy and the other two cases with severe inhalation burn were not successful in culturing. Average patient’s age was 37.8 years old and average body surface area burned was 50.9%. Five patients were flame burn, two were heat burn, two were chemical burn, and one was electrical burn. The average wound size was 778.6 cm2 and the average wound size covered by per vial of KerahealTM was 370.8 cm2. The intake rate was 95.48% and 99.5% at 2 weeks and 4 weeks respectively. The scar formations are still on going evaluation but most patients showed good results so far.
Conclusions: Cell suspension type of KerahealTM showed the excellent clinical efficacy in terms of the take rate and preventing scar formation in the severe burn wound. It is also more convenient to apply than the conventional type provided in a sheet type. (Journal of Korean Burn Society 2007;10:112-117)
|
|
|
KEYWORD
|
|
|
Major burns, Cultured epith
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|