CELLULAR CRYOPRESERVATIVE FORMULATIONS AND METHODS OF USE

Claims

Some aspects of the disclosure provide improved cryopreservative formulations and improved methods for cryopreserving and thawing cells. Cell preparations comprising a cell population and a cryopreservative formulation are also provided herein. Methods for treating a subject with a disease or condition that would benefit from transplantation of a cryopreserved and thawed cell population are also provided.

1. A formulation comprising (a) albumin, glucose, buffered saline, and one or two, optionally more, cryoprotectants selected from the group consisting of propanediol, dextran 40, proline, trehalose, glycerin, pentastarch, and ethylene glycol, optionally where the formulation is free of dimethyl sulfoxide (DMSO-free), (b) glucose, buffered saline, and one or two, optionally more, cryoprotectants selected from the group consisting of propanediol, dextran 40, proline, trehalose, glycerin, pentastarch, and ethylene glycol, optionally where the formulation is free of dimethyl sulfoxide (DMSO-free), (c) albumin, buffered saline, and one or two, optionally more, cryoprotectants selected from the group consisting of propanediol, dextran 40, proline, trehalose, glycerin, pentastarch and ethylene glycol, optionally where the formulation is free of dimethyl sulfoxide (DMSO-free), (d) buffered saline solution, and one or two, optionally more,(e) albumin, glucose, buffered saline solution, and one or two, optionally more, cryoprotectants selected from the group consisting of propanediol, dextran 40, proline, trehalose, glycerin, pentastarch and ethylene glycol, optionally where the formulation is free of dimethyl sulfoxide (DMSO-free), (f) glucose, buffered saline solution, and one or two, optionally more, cryoprotectants selected from the group consisting of propanediol, dextran 40, proline, trehalose, glycerin, hydroxyethyl starch and ethylene glycol, optionally where the formulation is free of dimethyl sulfoxide (DMSO-free), (g) albumin, buffered saline solution, and one or two, optionally more, cryoprotectants selected from the group consisting of propanediol,dextran 40, proline, trehalose, glycerin, hydroxyethyl starch, and ethylene glycol, optionally where the formulation is free of dimethyl sulfoxide (DMSO-free), or (h) buffered saline solution, and one or two cryoprotectants, optionally more, selected from the group consisting of propanediol, dextran 40, proline, trehalose, glycerin, hydroxyethyl starch, and ethylene glycol, optionally where the formulation is free of dimethyl sulfoxide (DMSO-free).

68. A cell preparation comprising a cell population in a 1:1 (v / v) mixture of (i) the formulation of any of claims 1-65 and (ii) a suspension solution comprising albumin, glucose, and buffered saline solution, each at the same concentration as in the formulation, wherein the suspension solution does not contain a cryoprotectant (albumin-free).

120. A method for preparing a cell preparation comprising contacting a cell population with (i) the formulation of any of claims 1-65 and (ii) a suspension solution comprising albumin, glucose and buffered saline solution, each at the same concentration as in the formulation, wherein the suspension solution does not contain a cryoprotectant (albumin-free).