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Product Holoderm? Company Tego Science, Inc
Classification Cell Therapy product Active Ingredient Autologous Keratinocytes
Reference Product Approval Date 2002
Indication Deep 2nd degree burn over 30% of TBSA
3rd degree burn over 10% of TBSA
Description

Holoderm? is Korea's first and world's second commercialized cultured skin autograft. A very small (1~3cm2) skin biopsy is taken from the patient suffering from a large 3rd degree burn wound, and the stem cells therefrom are cultured into sheet grafts, which are then transplanted on the patient's wound. Production takes 2-3 weeks, during which enough grafts can be obtained to cover the entire adult body surface. It is the most effective life-saver for the patient who has lost over 50% of his skin.

* Summary Characteristics
-Autologous cell therapy drug to treat large deep 2nd and 3rd degree burns with dermal loss.
-Patient's own keratinocytes are cultured into epidermal sheets and transplanted back on his wound.
-One graft contains one to four billion regenerative stem cells.
-No immunological rejection: 90% take rate in Phase III clinical trial.





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