US 12,433,916 B2
Cell bank of high concentration adipose-derived stem cell composition and related methods
Jens Kastrup, Birkerød (DK); Annette Ekblond, Birkerød (DK); and Mandana Haack-Sørensen, Vanløse (DK)
Assigned to Rigshospitalet, Copenhagen (DK)
Appl. No. 15/769,873
Filed by Rigshospitalet, Copenhagen Ø (DK)
PCT Filed Oct. 21, 2016, PCT No. PCT/EP2016/075407
§ 371(c)(1), (2) Date Apr. 20, 2018,
PCT Pub. No. WO2017/068140, PCT Pub. Date Apr. 27, 2017.
Claims priority of application No. 15191213 (EP), filed on Oct. 23, 2015.
Prior Publication US 2018/0325957 A1, Nov. 15, 2018
Int. Cl. A61K 35/28 (2015.01); A61K 9/00 (2006.01); A61K 38/19 (2006.01); A61P 3/10 (2006.01); A61P 19/02 (2006.01); A61P 19/08 (2006.01); A61P 29/00 (2006.01); A61P 37/06 (2006.01); C12N 5/0775 (2010.01)
CPC A61K 35/28 (2013.01) [A61K 9/0019 (2013.01); A61K 38/19 (2013.01); A61P 29/00 (2018.01); A61P 37/06 (2018.01); C12N 5/0667 (2013.01); A61P 3/10 (2018.01); A61P 19/02 (2018.01); A61P 19/08 (2018.01); C12N 2500/34 (2013.01); C12N 2500/38 (2013.01); C12N 2500/40 (2013.01); C12N 2500/44 (2013.01); C12N 2500/60 (2013.01); C12N 2500/62 (2013.01); C12N 2500/84 (2013.01)] 13 Claims
 
1. A cell bank comprising a plurality of vials stored under freezing conditions, each vial comprising a pharmaceutical composition comprising a suspension of an immunosuppressive adult human adipose-tissue derived stem cell (ASC) population in a protein-free cryoprotectant at a concentration in the range of 1.5×107 cells per mL to 5×107 cells per mL,
wherein at least 80% of the ASC population express CD90, CD105, CD13, CD73, CD166, and CD29, and at most 15% of the ASC population express CD45, CD31, CD14, and CD19,
wherein immediately after thawing a vial at least 80% of the stem cell population are viable cells, and
wherein the protein-free cryoprotectant comprises a 1:10 to 1:20 mixture of dimethyl sulfoxide (DMSO) and an aqueous solution comprising:
(a) one or more electrolytes selected from the group consisting of potassium ions at a concentration ranging from 35-45 mM, sodium ions ranging from 80-120 mM, magnesium ions ranging from 2-10 mM, and calcium ions ranging from 0.01-0.1 mM;
(b) a macromolecular oncotic agent selected from the group consisting of a polysaccharide and colloidal starch;
(c) a biological pH buffer;
(d) at least one of sucrose and glucose;
(e) mannitol;
(f) at least one impermeant anion selected from the group consisting of lactobionate, gluconate, citrate and glycerophosphate;
(g) at least one member selected from the group consisting of adenosine, fructose, ribose and adenine; and
(h) glutathione.