Claims for Patent: 5,759,764

Summary for Patent: 5,759,764

Title:	Cryopreservation solution
Abstract:	A simple, inexpensive, physiologically compatible, cryopreservation solution which includes the innocuous components of (i) glycerol, (ii) an alkali metal chloride salt, (iii) a monosaccharide, and (iv) serum albumin.
Inventor(s):	Polovina; Milo R. (Wayzata, MN)
Assignee:	Celox Laboratories, Inc. (St. Paul, MN)
Application Number:	08/658,666
Patent Claims:	1. A concentrated cryopreservation solution, consisting essentially of: (a) glycerol; (b) an alkali metal chloride salt in an amount effective for promoting cell viability; (c) a biologically metabolizable monosaccharide in an amount effective for supporting cell maintenance under ambient conditions; and (d) serum albumin in an amount effective for supporting plasma membrane integrity; (e) wherein the pH of the solution is between about 7 and 7.5. 2. The cryopreservation solution of claim 1 further including a diluent. 3. The concentrated cryopreservation solution of claim 1 wherein the alkali metal chloride salt is sodium chloride. 4. The concentrated cryopreservation solution of claim 1 wherein the monosaccharide is glucose. 5. The concentrated cryopreservation solution of claim 1 wherein the serum albumin is human serum albumin. 6. A method of cryopreserving cells, comprising (i) introducing target cells into the cryopreservation solution of claim 2, and (ii) cryopreserving the protected target cells. 7. The method of claim 6 wherein the volumetric ratio of target cell containing solution to cryopreservation solution is between about 1:1 to 1:10 and the ratio of target cells to cryopreservation solution is between about 1.times.10.sup.5 cells/ml to about 1.times.10.sup.9 cells/ml. 8. The method of claim 6 wherein the target cells are hematopoietic stem or progenitor cells. 9. The method of claim 6 wherein the target cells are blood platelet cells. 10. The method of claim 6 wherein the target cells are cells identified as CD 34+cells. 11. The method of claim 6 wherein the target cells are obtained from umbilical cord blood. 12. A method for cryopreserving and recovering viable cells, comprising (i) introducing target cells into the cryopreservation solution of claim 2, (ii) cryopreserving the protected target cells, and (iii) thawing the protected target cells. 13. The method of claim 12 wherein the volumetric ratio of target cell containing solution to cryopreservation solution is between about 1:1 to 1:10 and the ratio of target cells to cryopreservation solution is between about 1.times.10.sup.5 cells/ml to about 1.times.10.sup.9 cells/ml. 14. The method of claim 12 wherein the target cells are hematopoietic stem or progenitor cells. 15. A method for the cryopreservation, recovery and therapeutic use of cells, comprising (i) introducing target cells into the cryopreservation solution of claim 2, (ii) cryopreserving the protected target cells, (iii) thawing the protected target cells, and (iv) introducing the thawed protected target cells into a subject in need of such target cells without separation of the target cells and the cryopreservation solution. 16. The method of claim 15 wherein the volumetric ratio of target cell containing solution to cryopreservation solution is between about 1:1 to 1:10 and the ratio of target cells to cryopreservation solution is between about 1.times.10.sup.5 cells/ml to about 1.times.10.sup.9 cells/ml. 17. The method of claim 15 wherein the target cells are hematopoietic stem or progenitor cells. 18. The method of claim 15 wherein the target cells are blood platelet cells. 19. The method of claim 15 wherein the target cells are cells identified as CD 34+cells. 20. The method of claim 15 wherein the target cells are obtained from umbilical cord blood. 21. The method of claim 15 wherein the subject is a human.

Details for Patent 5,759,764

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2040-01-28
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2040-01-28
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2040-01-28
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2040-01-28
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2040-01-28
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003		2040-01-28
Csl Behring Llc	ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5	albumin (human)	Injection	103955	03/17/2000		2040-01-28