TREMTELECTOGENE EMPOGEDITEMCEL
UNII CT5FM8JN3S

Substance Identification & Data

This profile provides standardized clinical and technical data for Tremtelectogene Empogeditemcel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) CT5FM8JN3S.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number N/A and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

CT5FM8JN3S

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

TREMTELECTOGENE EMPOGEDITEMCEL

Official standardized name for this substance within the FDA UNII nomenclature system.

NCI Thesaurus

C180524

National Cancer Institute reference terminology for clinical and research data.

INN ID

12263

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

structurallyDiverse

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

ITIS TSN

180092

Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.

NCBI Taxonomy

9606

Unique numeric identifier used to specify biological species in the NCBI database.

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Tremtelectogene Empogeditemcel. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

Common Names & Synonyms

ALLOGENEIC HUMAN CD34 + HEMATOPOIETIC STEM AND PROGENITOR CELLS (HSPC) OBTAINED FROM PERIPHERAL BLOOD BY LEUKAPHERESIS FROM HUMAN LEUKOCYTE ANTIGEN (HLA)-MATCHED HEALTHY DONORS, GENETICALLY MODIFIED EX VIVO BY CRISPR/CAS9 (CLUSTERED REGULARLY INTERSPACED SHORT PALINDROMIC REPEATS (CRISPR)-ASSOCIATED PROTEIN-9 (CAS9)) NUCLEASE, COMPLEXED WITH A GUIDE RNA (GRNA) THAT BINDS TO A 20-BASE PAIR TARGET DNA SEQUENCE AT THE INTRON 2/EXON 3 BOUNDARY OF THE SIALIC ACID BINDING IG-LIKE LECTIN 3 (SIGLEC-3, CD33) GENE, WHICH INTRODUCES A PREMATURE STOP CODON AND DEGRADATION OF THE MRNA SUCH THAT NO FUNCTIONAL CD33 IS EXPRESSED (THE CELL SUSPENSION IS ENRICHED FOR CD34+ CELLS USING MAGNETIC BEAD SEPARATION. FOLLOWING ELECTROPORATION, THE CELLS ARE CULTURED IN MEDIA CONTAINING STEM CELL FACTOR (SCF), FMS-RELATED TYROSINE KINASE 3 LIGAND (FLT-3L), AND THROMBOPOIETIN (TPO). THE SUBSTANCE CONSISTS OF CELLS WITH >=90% CD34 PURITY AND >=50% ON-TARGET EDITING OF CD33

TREMTELECTOGENE EMPOGEDITEMCEL [INN]

Technical Codes

TREMTELECTOGENE EMPOGEDITEMCEL

External Clinical & Regulatory Resources

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