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.
Claims20
A mesenchymal stem cell (MSC) preparation comprising:
- a. at least about 1 billion human bone marrow-derived MSCs;
- and
- b. an antigen profile comprising:
- i. less than about 0.75% CD45+ cells;
- ii. at least about 95% CD105+ cells;
- and
- iii. at least about 95% CD166+ cells.
A method of making an MSC preparation comprising the steps of:
- a. making a plurality of preparations, each preparation made by the steps comprising:
- i. obtaining from a single donor at least about 70 ml of non-fetal human bone marrow aspirate containing viable cells;
- ii. expanding by passage expansion the number of viable cells to provide a preparation of at least about 1 billion of the viable cells, wherein the passage expansion comprises establishing a primary culture of isolated MSCs and then serially establishing at least a first non-primary (P1) culture of isolated MSCs from the previous culture;
- and
- b. selecting from the plurality of preparations at least one preparation that has an antigen profile comprising:
- i. less than about 0.75% CD45+ cells;
- ii. at least about 95% CD105+ cells;
- and
- iii. at least about 95% CD166+ cells;
- and
- c. optionally, wherein the step of selecting comprises testing the at least one preparation to determine the percent CD45+ cells, the percent CD1055+ cells, the percent CD166+ cells.
Dependencies are inferred from the claim text.