ENVURETCEL
UNII KXL6JKJ295

Substance Identification & Data

This profile provides standardized clinical and technical data for Envuretcel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) KXL6JKJ295.

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

KXL6JKJ295

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ENVURETCEL

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

NCI Thesaurus

C216021

National Cancer Institute reference terminology for clinical and research data.

INN ID

12645

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

NO-16

Identifier assigned by the United States Adopted Names Council.

Substance Type

Envuretcel

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

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Envuretcel. 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.

FDA Official Name

Envuretcel

Common Names & Synonyms

Allogeneic Human Embryonic Stem Cell Derived Retinal Pigment Epithelial Cells

Allogeneic retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESC). The hESC are expanded in a defined, serum-free, xeno-free culture medium on plates containing mitomycin C (MitC)-inactivated human dermal fibroblast (HDF) feeder cells, seeded initially on laminin/E-cadherin and finally on a reconstituted basement membrane matrix to generate a master cell bank (MCB). The manufacturing of the human embryonic stem cell-derived retinal pigment epithelial (hESC-RPE) cells consists of 4 phases. First, expansion of the MCB-derived hESCs on plates containing MitC inactivated HDF feeder cells, coated with laminin/E-cadherin. Second, the hESCs are induced to differentiate into RPE cells in embryoid body differentiation medium (EBDM) over a time frame of 80-140 days. Third, the resulting pigmented clusters are dissociated and expanded on gelatin-coated plates, in media containing a serum replacement additive, fetal bovine serum, basic human fibroblast growth factor (bhFGF) and 2-mercaptoethanol, with the cells monitored for medium pigmentation and typical cobblestone epithelial morphology. Finally, the cells are tested for expression of RPE-specific markers (bestrophin-1 [BEST1] and/or paired box 6 [PAX6]), before cell harvest (step 4). The final cell population is characterized by the upregulation of RPE specific cell marker (BEST1, PAX6, microphthalmia-associated transcription factor [MITF] and RPE-65), downregulation of embryonic stem cell genes (NANOG, octamer-binding transcription factor 4 [OCT4] and SOX-2) and the capability to phagocytose fluorescence particles (≥40%)), albumin (human) 20% (20% w/v), Dextran 40 in dextrose (25% v/v) and dimethyl sulfoxide (5.0% v/v).

ENVURETCEL [USAN]

HESC-RPE CELLS

HUMAN EMBRYONIC STEM CELL-DERIVED RPE