Clinical formulations
AssigneeAstellas Institute for Regenerative Medicine
InventorsRoger Gay, Judson Ratliff, Romma E. Southwick
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Abstract
Some aspects of this disclosure provide clinical media that support viability, re-plating efficiency, and repopulation capacity of cells and tissues during storage for up to 48 hours or longer. The clinical media provided herein are also useful for clinical irrigation. Cell or tissue preparations comprising a cell population or tissue and a clinical medium as provided herein are also provided, as are methods for generating such preparations. Methods for using the clinical media and cell and tissue preparations provided herein, for example, for administering an effective amount of cells or tissue to a subject in need thereof, are also disclosed.
Claims29
A method for treating a retinal disease, the method comprising
- administering, to the eye of a human subject having a retinal disease, an effective amount of a pharmaceutical composition comprising
- (a) a population of cells, and
- (b) a solution comprising
- (i) about 0.1-1.2 mM CaCl2, about 0.05-5 mM MgCl2, about 1-2.5 mM KCl, about 0.5-2 mM sodium citrate, about 15-17 mM dextrose, and about 125-175 mM NaCl, or
- (ii) about 0.5-0.9 mM CaCl2, about 0.2-0.4 mM MgCl2, about 1.6-2.4 mM KCl, about 0.8-1.2 mM sodium citrate, about 13-19 mM dextrose, and about 116-174 mM NaCl, or
- (iii) about 0.008-0.012% CaCl2 dihydrate, about 0.0048-0.0072% MgCl2 hexahydrate, about 0.012-0.018% KCl, about 0.028-0.042% sodium citrate dihydrate, about 0.23-0.35% dextrose, and about 0.68-1.02% NaCl.
A method for treating a human subject in need of cellular therapy comprising
- (a) reconstituting a population of cells with a solution comprising
- (i) about 0.1-1.2 mM CaCl2, about 0.05-5 mM MgCl2, about 1-2.5 mM KCl, about 0.5-2 mM sodium citrate, about 15-17 mM dextrose, and about 125-175 mM NaCl, or
- (ii) about 0.5-0.9 mM CaCl2, about 0.2-0.4 mM MgCl2, about 1.6-2.4 mM KCl, about 0.8-1.2 mM sodium citrate, about 13-19 mM dextrose, and about 116-174 mM NaCl, or
- (iii) about 0.008-0.012% CaCl2 dihydrate, about 0.0048-0.0072% MgCl2 hexahydrate, about 0.012-0.018% KCl, about 0.028-0.042% sodium citrate dihydrate, about 0.23-0.35% dextrose, and about 0.68-1.02% NaCl, and
- (b) administering an effective amount of the reconstituted population of cells to a subject in need thereof.
Dependencies are inferred from the claim text.