Clinical formulations
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.
1. A solution for cell reconstitution, storage, transport and/or administration to a subject comprising
(a) a buffer, maintaining the solution at a physiological pH, optionally wherein the buffer is an acetate buffer and/or a citrate buffer;
(b) 13-19 mM glucose;
(c) 1-2.5 mM KCl;
(d) an osmotically active agent maintaining the solution at a physiological osmolarity; and
(e) a source of divalent cations, comprising a calcium source and a magnesium source,
wherein the solution does not comprise a carbonate buffer or a zwitterionic organic buffer, and further does not comprise glutathione or glutathione disulfide.
2. The solution of claim 1 , wherein the glucose is present at a concentration of 15-17 mM.
3. The solution of claim 1 , wherein glucose is dextrose.
4. The solution of claim 1 , wherein the solution further comprises potassium chloride at a concentration of 1.6-2.4 mM KCl.
5. The solution of claim 1 , wherein the solution is heat sterilized.
6. The solution of claim 1 , further comprising cells.
7. A preparation comprising a solution for cell reconstitution, storage, transport and/or administration to a subject and retinal pigment epithelial (RPE) cells, the solution comprising
(a) a buffer, maintaining the solution at a physiological pH, optionally wherein the buffer is an acetate buffer and/or a citrate buffer;
(b) 13-19 mM glucose;
(c) an osmotically active agent maintaining the solution at a physiological osmolarity; and
(d) a source of divalent cations, comprising a calcium source and a magnesium source, wherein the solution does not comprise a carbonate buffer or a zwitterionic organic buffer, and further does not comprise glutathione or glutathione disulfide.
8. A preparation comprising a solution for cell reconstitution, storage, transport and/or administration to a subject and photoreceptor cells, the solution comprising
(a) a buffer, maintaining the solution at a physiological pH, optionally wherein the buffer is an acetate buffer and/or a citrate buffer;
(b) 13-19 mM glucose;
(c) an osmotically active agent maintaining the solution at a physiological osmolarity; and
(d) a source of divalent cations, comprising a calcium source and a magnesium source, wherein the solution does not comprise a carbonate buffer or a zwitterionic organic buffer, and further does not comprise glutathione or glutathione disulfide.
9. A preparation comprising a solution for cell reconstitution, storage, transport and/or administration to a subject and mesenchymal cells, the solution comprising
(a) a buffer, maintaining the solution at a physiological pH, optionally wherein the buffer is an acetate buffer and/or a citrate buffer;
(b) 13-19 mM glucose;
(c) an osmotically active agent maintaining the solution at a physiological osmolarity; and
(d) a source of divalent cations, comprising a calcium source and a magnesium source, wherein the solution does not comprise a carbonate buffer or a zwitterionic organic buffer, and further does not comprise glutathione or glutathione disulfide.
10. A solution for cell reconstitution, storage, transport and/or administration to a subject comprising calcium chloride, magnesium chloride, sodium citrate, sodium chloride, glucose, potassium chloride, and a viscoelastic polymer in an aqueous solution,
wherein the glucose is present at a concentration of 13-19 mM,
wherein the potassium chloride is present at a concentration of 1-2.5 mM KCl,
wherein the solution does not comprise a carbonate buffer or a zwitterionic organic buffer, and further does not comprise glutathione or glutathione disulfide.
11. The solution of claim 10 , wherein the glucose is present at a concentration of 15-17 mM.
12. The solution of claim 10 , wherein glucose is dextrose.
13. The solution of claim 10 , wherein the solution comprises potassium chloride at a concentration of 1.6-2.4 mM KCl.
14. The solution of claim 10 , wherein the solution is heat sterilized.
15. The solution of claim 10 , further comprising cells.
16. A preparation comprising the solution of claim 10 and retinal pigment epithelial (RPE) cells.
17. A preparation comprising the solution of claim 10 and photoreceptor cells.
18. A preparation comprising a solution for cell reconstitution, storage, transport and/or administration to a subject and mesenchymal cells, the solution comprising calcium chloride, magnesium chloride, sodium citrate, sodium chloride, glucose, potassium chloride, and a viscoelastic polymer in an aqueous solution,
wherein the solution does not comprise a carbonate buffer or a zwitterionic organic buffer, and further does not comprise glutathione or glutathione disulfide.