Enhanced MSC preparations
AssigneeMesoblast International Sarl
InventorsSamson Tom, Christopher Ton, Alla Danilkovitch
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Abstract
The present invention provides preparations of MSCs with important therapeutic potential. The MSC cells are non-primary cells with an antigen profile comprising less than about 1.25% CD45+ cells (or less than about 0.75% CD45+), at least about 95% CD105+ cells, and at least about 95% CD166+ cells. Optionally, MSCs of the present preparations are isogenic and can be expanded ex vivo and cryopreserved and thawed, yet maintain a stable and uniform phenotype. Methods are taught here of expanding these MSCs to produce a clinical scale therapeutic preparations and medical uses thereof.
Claims16
A mesenchymal stem cell (MSC) preparation comprising:
- cultured human bone-marrow-derived MSCs expanded from a cryopreserved in-process intermediate MSC preparation;
- wherein the cultured human bone-marrow-derived MSCs
- (a) have an antigen profile comprising:
- i. less than 0.75% CD45+ cells;
- ii. at least 95% CD105+ cells;
- and
- iii. at least 95% CD166+ cells;
- and
- (b) are capable of inhibiting IL2Rα expression by CD3/CD28-activated PBMCs by at least 30% relative to a control.
A frozen cell suspension composition comprising:
- (a) cultured human bone-marrow-derived MSCs expanded from a cryopreserved in-process intermediate MSC preparation with an antigen profile comprising:
- i. less than 0.75% CD45+ cells;
- ii. at least 95% CD105+ cells;
- and iii. at least 95% CD166+ cells;
- wherein the cultured human bone-marrow-derived MSCs are capable of inhibiting IL2Ra expression by CD3/CD28-activated PBMCs by at least 30% relative to a control;
- (b) an electrolyte solution,
- (c) 5% human serum albumin, and
- (d) 10% DMSO.
A method of treating steroid refractory acute Graft versus Host Disease (aGvHD) in a pediatric patient comprising intravenously administering eight biweekly therapeutic doses of 2×106 mesenchymal stem cells/kg.
Dependencies are inferred from the claim text.