Enhanced MSC preparations
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.
1. A mesenchymal stem cell (MSC) preparation comprising:
a. at least 1 billion cultured human MSCs expanded from a cryopreserved in-process intermediate MSC preparation; and
b. an antigen and activity profile comprising:
i. less than 0.75% CD45+ cells;
ii. at least 95% CD105+ cells;
iii. at least 95% CD166+ cells; and
iv. capable of inhibiting IL2Rα expression by CD3/CD28-activated PBMCs by at least 30% relative to a control.
2. The MSC preparation of claim 1 , wherein the MSCs express at least 13 pg TNFR1 per million MSCs.
3. The MSC preparation of claim 1 , wherein the MSCs express at least 108 pg/mL TNFR1.
4. The MSC preparation of claim 1 , wherein the MSCs express about 13 pg to about 179 pg TNFR1 per million MSCs.
5. The MSC preparation of claim 1 , wherein the MSCs express about 13 pg to about 44 pg TNFR1 per million MSCs.
6. The MSC preparation of claim 1 , wherein the MSCs express 108 pg/mL to 368 pg/mL TNFR1.
7. The MSC preparation of claim 1 , wherein the MSCs express TNFR1 at a minimum of 272 pg/mL and a maximum of 1471 pg/mL.