Method of producing natural killer cells and composition for treating cancer
A method for producing natural killer cells is disclosed. The method comprises isolating peripheral blood mononuclear cells (PBMCs) from a blood sample; isolating at least one of CD56+ cells and/or CD3−/CD56+ cells from the PBMCs; and co-culturing the at least one of CD56+ cells and/or CD3−/CD56+ cells with a combination of feeder cells in the presence of a cytokine. A composition for treating cancer is also disclosed. The composition comprises the CD56+ natural killer cells produced by the disclosed method and a cytokine.
1. A cell therapeutic composition, comprising:
a therapeutically effective amount of at least one of CD56+ and/or CD3−/CD56+ NK cells, wherein purity of the NK cells in the cell therapeutic composition is at least 90% relative to other cells in the cell therapeutic composition;
IL-2 at a concentration of 50-50,000 IU/mL; and
a pharmaceutically acceptable carrier,
wherein the cell therapeutic composition is in a form suitable for administration to a human patient in need of NK cell therapy.
2. The composition of claim 1 , wherein the therapeutically effective amount is 1×10 6 to 1×10 11 NK cells per kg of body weight of the human patient.
3. The composition of claim 2 , wherein the composition is at about 4 degrees centigrade.
4. The cell therapeutic composition of claim 1 , wherein IL-2 is present at 50-1,000 IU/mL.
5. The cell therapeutic composition of claim 4 , wherein the cell therapeutic composition does not comprise IL-21.
6. The cell therapeutic composition of claim 5 , wherein the cell therapeutic composition is between 2 and 8° C.
7. The cell therapeutic composition of claim 6 , wherein the cell therapeutic composition is at about 4 degrees centigrade.
8. The cell therapeutic composition of claim 1 , wherein IL-2 is present at about 500 IU/mL.
9. A bag containing a cell composition, the composition comprising:
1×10 6 to 1×10 11 NK cells per kg of body weight of a human subject, wherein the NK cells are CD56+ and/or CD3−/CD56+ cells derived from peripheral blood mononuclear cells (PBMCs), wherein the NK cells are at least about 90% pure, wherein less than about 1% of cells in the bag are T cells;
IL-2 at a concentration of 50-50,000 IU/mL; and
a pharmaceutically acceptable carrier comprising Hartmann's solution, albumin, DMSO and no IL-21.
10. A cell composition, comprising:
at least one of CD56+ and/or CD3−/CD56+ NK cells, wherein purity of the NK cells in the cell composition is at least 90% relative to other cells in the cell composition;
IL-2 at a concentration of 50-50,000 IU/mL;
a pharmaceutically acceptable carrier comprising:
DMSO, and
no IL-21,
wherein the cell composition is in a form suitable for administration to a human patient.
11. The cell composition of claim 10 , wherein IL-2 is present at 50-1,000 IU/mL.
12. The cell composition of claim 11 , further comprising Hartmann's solution.
13. The cell composition of claim 12 , further comprising albumin.
14. The cell composition of claim 13 , wherein the albumin is present at 1%.
15. The cell therapeutic composition of claim 13 , wherein IL-2 is present at about 500 IU/mL.
16. The cell composition of claim 13 , wherein the cell composition is between 2 and 8° C.
17. The composition of claim 13 , wherein the composition is at about 4 degrees centigrade.
18. A cell composition, comprising:
at least one of CD56+ and/or CD3−/CD56+ NK cells, wherein purity of the NK cells in the cell composition is at least 90% relative to other cells in the cell composition;
IL-2 at a concentration of 500-50,000 IU/mL;
a pharmaceutically acceptable carrier,
wherein the cell composition is in a form suitable for administration to a human patient.
19. The cell composition of claim 18 , wherein the cells have been stored for at least 24 hours.
20. The cell composition of claim 18 , wherein the cells have been stored for at least 48 hours.