Prademagene Zamikeracel

U.S. Department of Health & Human Services Divider Arrow

National Institutes of Health Divider Arrow

NCATS

Investigational

Investigational

Approval Year

Substance Class	Structurally Diverse Created by `admin` on `Wed Apr 02 09:53:22 GMT 2025` Edited by `admin` on `Wed Apr 02 09:53:22 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	keritinocyte
Record UNII	4UU2O40RHU
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

EB-101

Preferred Name

English

Prademagene Zamikeracel

Official Name

English

Human culture expanded genetically modified autologous keratinocytes for cell-based gene therapy. Cells are isolated from skin of the patient, expanded and transduced with replication incompetent and non-self-inactivating Moloney murine leukemia virus (M

Common Name

English

PRADEMAGENE ZAMIKERACEL [USAN]

Common Name

English

prademagene zamikeracel [INN]

Common Name

English

Code System Code Type Description

NCI_THESAURUS

C175196

Created by admin on Wed Apr 02 09:53:22 GMT 2025 , Edited by admin on Wed Apr 02 09:53:22 GMT 2025

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INN

10827

Created by admin on Wed Apr 02 09:53:22 GMT 2025 , Edited by admin on Wed Apr 02 09:53:22 GMT 2025

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SMS_ID

100000181393

Created by admin on Wed Apr 02 09:53:22 GMT 2025 , Edited by admin on Wed Apr 02 09:53:22 GMT 2025

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FDA UNII

4UU2O40RHU

Created by admin on Wed Apr 02 09:53:22 GMT 2025 , Edited by admin on Wed Apr 02 09:53:22 GMT 2025

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CAS

2088280-15-1

Created by admin on Wed Apr 02 09:53:22 GMT 2025 , Edited by admin on Wed Apr 02 09:53:22 GMT 2025

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USAN

GH-133

Created by admin on Wed Apr 02 09:53:22 GMT 2025 , Edited by admin on Wed Apr 02 09:53:22 GMT 2025

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Related Record Type Details


					4UU2O40RHU

Prademagene Zamikeracel

ACTIVE MOIETY

Amount:

Agent Modifications

Modification Process	Modification Role	Modification Type	Amount	Fragment Name	Fragment ID
Other	TRANSGENE INTEGRATION	RETROVIRAL TRANSFECTION		EB-101 NON-REPLICATING RETROVIRAL MMLV VECTOR ENCODING THE FUNCTIONAL COLLAGEN TYPE VII ALPHA 1 CHAIN	261E5577AL

Structural Modifications

Modification Type	Location Site	Location Type	Residue Modified	Extent	Fragment Name	Fragment Approval
GENE_EXPRESSION VECTOR					EB-101 TRANSGENE INSERT	E0UDB8HXM4
VECTOR EXPRESSED PROTEIN					COLLAGEN ALPHA-1(VII) CHAIN	1AH5NN82CT