Extended indication Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Regenerative Skin Tissue
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Skin diseases
Extended indication Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements.
Proprietary name StrataGraft
Manufacturer Mallinckrodt
Budgetting framework Intermural (MSZ)
Additional comments StrataGraft skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes.

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Primary completion datum van fase 3 studie in juli 2019.

Therapeutic value

Current treatment options De huidige behandeling bestaat uit het verwijderen van de dode huid en het beleggen met een huidtransplantaat afkomstig van een plek op de huid die onaangetast is.
Therapeutic value No estimate possible yet
References NCT03005106

Expected patient volume per year

Patient volume

< 1,000

Market share is generally not included unless otherwise stated.

References Brandwondenstichting.nl
Additional comments De studie includeert patiënten waarvan 3%-49% van het totale lichaamsoppervlakte aangetast is door brandwonden waarvoor excisie en autograft geïndiceerd is. Elk jaar worden rond de 1.000 patiënten opgenomen in één van de drie brandwondencentra vanwege brandwonden of ander ernstig huidletsel.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.