Expandable Clinical Grade Feeder Cells for hESc Derivation

We aim to generate an inexhaustible supply of immortalised clinical grade human dermal fibroblasts (hDFs) for derivation of cGMP hESc lines. Human Embryonic stem cells (hESc) have great potential for use in clinical therapies but current hESc lines have not been generated under conditions suitable for clinical use. We will exploit our successful TSB-funded feasibility study to generate suitable immortalised human dermal fibroblasts (hDFs) for derivation of cGMP hESc lines. We will immortalise 2 primary (clinical grade) hDF lines, already shown to support culture and derivation of cGMP hESc lines in a unique media system, using a method shown by us to generate hESc-supportive feeder cells at the research level. The immortalised cells will be tested for derivation of new cGMP hESc lines and will provide a supply of marketable cGMP feeder cells for use in generating hESc for therapy.

We aim to generate an inexhaustible supply of immortalised clinical grade human dermal fibroblasts (hDFs) for derivation of cGMP hESc lines. Human Embryonic stem cells (hESc) have great potential for use in clinical therapies but current hESc lines have not been generated under conditions suitable for clinical use. We will exploit our successful TSB-funded feasibility study to generate suitable immortalised human dermal fibroblasts (hDFs) for derivation of cGMP hESc lines. We will immortalise 2 primary (clinical grade) hDF lines, already shown to support culture and derivation of cGMP hESc lines in a unique media system, using a method shown by us to generate hESc-supportive feeder cells at the research level. The immortalised cells will be tested for derivation of new cGMP hESc lines and will provide a supply of marketable cGMP feeder cells for use in generating hESc for therapy.

HESc are envisioned to play a major future role in the RM industry with market potentials in the region of $100 billion (MaRS report 2009). For this impact to be realised, of the many advances needed, one critical step is the ability to derive and grow clinical grade hESc which can be targeted to desired target cells. We seek to fill this gap in the RM market by producing xeno-free immortalised human feeder cells of validated ability to support derivation of hESc under stringent clinically acceptable conditions. Since there are no commercial sources of expandable xeno-free cGMP human feeder cells suitable for hESc growth and derivation that can be used as an alternative, what we propose is a unique opportunity to enhance UK and Europe's RM and possibly that outside Europe. Biotime (US) market only animal product-exposed hDFs which are not immortalised and thus not a significantly expandable supply as they carry the risk of losing their supportive ability with increased expansion. Our expandable cells will likely also function for the generation and culture of ES-like cells derived from somatic tissue (induced pluripotent somatic, ips, cells) which might form an alternative source of tissue for clinical therapy in the future. Critically, the further development of the hDF feeder lines through our immortalisation method will lead to a unique and fully expandable source of cells for commercial exploitation and this will be promoted and marketed commercially through the activities of XCellR8.