DABOCEMAGENE AUTOFICEL

Approval Year

Substance Class	Structurally Diverse Created by `admin` on `Wed Apr 02 04:02:49 GMT 2025` Edited by `admin` on `Wed Apr 02 04:02:49 GMT 2025`
Source Materials Class	ORGANISM
Source Materials Type	AUTOLOGOUS HUMAN
Source Materials State	LIVE GENETICALLY MODIFIED
Source Materials Parent	`G0T704E6Z3` HOMO SAPIENS WHOLE
Part	skin
Fraction Material Type	cells
Fraction Name	fibroblast
Record UNII	0S9A4XK1WT
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

DABOCEMAGENE AUTOFICEL

Official Name

English

FCX-007

Preferred Name

English

DNA (RECOMBINANT LENTIVIRUS VECTOR INXN-2004-TRANSDUCED HUMAN AUTOLOGOUS DYSTROPHIC EPIDERMOLYSIS BULLOSA DERMAL FIBROBLAST CELL FCX-007 INTEGRATED PROVIRAL HUMAN COLLAGEN TYPE VII TRANSGENE COL7A1 PLUS 5'-HUMAN CYTOMEGALOVIRUS PROMOTER/UTR-AND 3'-LTR/PO

Common Name

English

AUTOLOGOUS HUMAN DERMAL FIBROBLAST CELLS DERIVED FROM SKIN BIOPSIES, AND TRANSDUCED WITH A NON-REPLICATING, SELF-INACTIVATING LENTIVIRUS VECTOR THAT ENCODES HUMAN COLLAGEN TYPE VII ALPHA 1 (COL7A1) UNDER THE CONTROL OF A HUMAN CYTOMEGALOVIRUS (CMV) PROMO

Common Name

English

dabocemagene autoficel [INN]

Common Name

English

DABOCEMAGENE AUTOFICEL [USAN]

Common Name

English

Code System Code Type Description

SMS_ID

100000184275