Cell potency assay for therapeutic potential
AssigneeFate Therapeutics, Inc.
InventorsDaniel Shoemaker, David L. Robbins
Life of this patent
Estimating the term…
Abstract
The invention provides cell potency assays for measuring, determining, identifying, confirming, or validating the therapeutic potential of a cell population. Cell potency assays may be performed with various types of cells, including stem or progenitor cells, such as, for example, hematopoietic stem or progenitor cells. Cell potency assays may also be performed on stem or progenitor cells that have been treated with one or more agents to enhance therapeutic potential. Hematopoietic cells having therapeutic potential are useful in downstream clinical applications for increasing engraftment, reconstitution, homing, and proliferation in vivo.
Claims20
A method for treating a subject in need of cell based therapy with a population of hematopoietic cells having therapeutic potential comprising:
- a) validating therapeutic potential of the cell population by:
- i) measuring expression of a plurality of signature genes in the cell population;
- ii) calculating a score using gene expression clustering of expression measured for the plurality of signature genes in said cell population to expression measured for the plurality of signature genes in control cells that lack therapeutic potential and to expression measured for the plurality of signature genes in control cells with optimal therapeutic potential;
- and
- iii) identifying the cell population as having therapeutic potential if the score is greater than or equal to a predetermined cut-off value, and
- b) administering a therapeutically effective amount of the cell population having therapeutic potential to the subject;
- wherein the plurality of signature genes comprises cAMP-responsive element modulator (CREM), GTP-binding protein GEM (GEM), nuclear receptor subfamily 4, group A, member 2 (NR4A2), nuclear receptor subfamily 4, group A, member 3 (NR4A3), interleukin IA (ILIA), hairy/enhancer-of-split related with YRPW motif 1 (HEY1), chemokine (C-X-C motif) ligand 2 (CXCL2), chemokine (C-X-C motif) ligand 3 (CXCL3), and UL16 binding protein 2 (ULBP2).
Dependencies are inferred from the claim text.