Claims for Patent: 7,255,983

Summary for Patent: 7,255,983

Title:	Evaluation and preservation solution
Abstract:	An evaluation and preservation solution for human and animal organs, tissues and parts thereof is described, wherein it comprises serum albumin at a concentration of 55-105 g/L, a scavenger and coating compound, preferably dextran compounds and derivatives thereof having essentially the same structure at a concentration of 1-55 g/L weight, and a physiological serum concentration of salts and nutrients in a physiologically acceptable medium.
Inventor(s):	Steen; Stig (Lund, SE)
Assignee:	Vitrolife AB (Gothenburg, SE)
Application Number:	10/415,740
Patent Claims:	1. An evaluation and preservation solution for human and animal organs, tissues and parts thereof, comprising (a) serum albumin at a concentration of 55-105 g/L, (b) a dextran compound which coats the capillary endothelium of the organs, tissues or parts thereof at a concentration of 1-55 g/L, said dextran compound comprising dextran molecules (c) a physiological serum concentration of salts, and (d) nutrients for the organs, tissues or parts thereof, in a physiologically acceptable medium, and provides an oncotic pressure higher than an applied hydrostatic pressure in the organs, tissues or parts thereof, and wherein the solution prevents oedema formation. 2. The evaluation and preservation solution according to claim 1, wherein the dextran compound has a molecular weight ranging from 20 to 150 kDa. 3. The evaluation and preservation solution according to claim 2, wherein the concentration of serum albumin is 65-85 g/L and the concentration of the dextran compound is 2-20 g/L. 4. The evaluation and preservation solution according to claim 1, wherein the concentration of serum albumin is 65-85 g/L and the concentration of the dextran compound is 2-20 g/L. 5. The evaluation and preservation solution according to claim 1, wherein the salts comprise one or more of sodium, potassium, calcium, magnesium, phosphate, hydrogen carbonate and chloride ions; and the nutrients comprise one or more of physiologically acceptable carbohydrates, fatty acids and amino acids. 6. The evaluation and preservation solution according to claim 5, wherein the physiologically acceptable carbohydrate is glucose. 7. The evaluation and preservation solution according to claim 1, further comprising one or more of the following: a vasodilator; an antibiotic; a fibrinolytic component; a thrombocyte receptor blocker; and a hormone; an insulin; a cortisol; a growth hormone; an anabolic steroid; or a combination thereof. 8. The evaluation and preservation solution according to claim 1, further comprising a pure scavenger compound. 9. The evaluation and preservation solution according to claim 8, wherein the pure scavenger compound is allopurinol, vitamin E, vitamin C, didox or trimidox, a compound having endothelial coating effects, or a combination thereof. 10. The evaluation and preservation solution according to claim 1, wherein the serum albumin is human or animal serum albumin or recombinant serum albumin produced by genetic engineering. 11. The evaluation and preservation solution according to claim 10, further comprising a hyaluronic acid-based compound having a molecular weight of about 69 kDa. 12. The evaluation and preservation solution according to claim 1, wherein the organs are lungs, hearts, kidneys, livers, pancreas, or small bowels. 13. The evaluation and preservation solution according to claim 1, wherein the dextran compound comprises dextran molecules ranging from 1 to 250 kDa. 14. The evaluation and preservation solution according to claim 1, wherein the dextran compound comprises dextran molecules ranging from 15 to 115 kDa. 15. The evaluation and preservation solution according to claim 1, wherein the dextran compound is Dextran 40, Dextran 60, Dextran 70, or a combination thereof. 16. The evaluation and preservation solution according to claim 1, wherein the concentration of serum albumin is 70 g/L. 17. The evaluation and preservation solution according to claim 1, wherein the concentration of the dextran compound is 5 g/L. 18. The evaluation and preservation solution according to claim 1, further comprising papaverin, altepas, abciximab, tyroxin/triiodotyronin, or a combination thereof. 19. The evaluation and preservation solution according to claim 1, wherein the concentration of the serum albumin is 65-85 g/L; the concentration of the dextran compound is 2-20 g/L; and the dextran compound has a molecular weight ranging from 20-150 kDa. 20. A method of preserving an animal or human organ, tissue, or part thereof for observation prior to transplanting said organ, tissue or part thereof which comprises perfusing the organ, tissue or part thereof with the solution of claim 1. 21. A ready to use, mixed evaluation and preservation solution for human and animal organs, tissues and parts thereof comprising: red blood cells with an erythrocyte volume fraction of 15%.+-.5%, serum albumin at a concentration of 50-100 g/L, and a dextran compound at a concentration of 1-50 g/L. 22. The ready to use solution of claim 21, wherein the concentration of the serum albumin is 60-80 g/L. 23. The ready to use solution of claim 21, wherein the concentration of the dextran compound is 2-20 g/L. 24. The ready to use solution of claim 21, wherein the dextran compound has a molecular weight ranging from 20 to 150 kDa. 25. The ready to use solution of claim 21, wherein the concentration of serum albumin is 65-85 g/L and the concentration of the dextran compound is 2-20 g/L. 26. The ready to use solution of claim 21, wherein the salts comprise one or more of sodium, potassium, calcium, magnesium, phosphate, hydrogen carbonate and chloride ions; and the nutrient comprising one or more of physiologically acceptable carbohydrates, fatty acids and amino acids. 27. The ready to use solution of claim 21, further comprising one or more of the following: a vasodilator, an antibiotic, a fibrinolytic component, a thrombocyte receptor blocker, a hormone, an insulin, a cortisol, a growth hormone, an anabolic steroid or a combination thereof. 28. The ready to use solution of claim 21, further comprising a pure scavenger compound. 29. The ready to use solution of claim 21, wherein the serum albumin is human serum albumin or an animal serum albumin or recombinant serum albumin produced by genetic engineering. 30. The ready to use solution of claim 21, further comprising a hyaluronic acid-based compound having a molecular weight of about 69 kDa. 31. The ready to use solution of claim 21, wherein the organs are lungs, hearts, kidneys, livers, pancreas or small bowels. 32. The ready to use solution of claim 21, wherein the concentration of serum albumin is 65-85 g/L; the concentration of the dextran compound is 2-20 g/L; and the dextran compound has a molecular weight ranging from 20-150 kDa. 33. A method for the evaluation of human and animal organs, tissues and parts thereof for transplantation, which comprises perfusing the organ, tissue or part thereof with the solution according to anyone of claims 21, 22, 23 and 24-32, measuring the evaluation parameters, and optionally preserving the perfused and accepted organ, tissue or part thereof in said solution until transplantation thereof. 34. The method according to claim 33, wherein the organ is a lung. 35. A method for the transplantation of an organ, tissue or a part thereof from a non-heart-beating human or animal donor comprising perfusing the organ, tissue or part thereof which is harvested from the donor body with the solution according to anyone of claims 21, 22, 23 and 24-32, evaluating if the organ, tissue or part thereof is acceptable for transplantation, transplanting the organ, tissue or part thereof into a donor, and optionally preserving the organ, tissue or part thereof in said solution until transplantation. 36. The method according to claim 35, wherein the organ, tissue or part thereof is auto-, allo- or xenotransplanted. 37. A method of preserving an animal or human organ, tissue, or part thereof for observation prior to transplanting said organ, tissue or part thereof which comprises perfusing the organ, tissue or part thereof with the solution of anyone of claims 21, 22, 23 and 24-32. 38. An evaluation and preservation solution for human and animal organs, tissues and parts thereof, comprising (a) serum albumin at a concentration of 70 g/L, (b) a dextran compound which coats the capillary endothelium of the organ, tissues or parts thereof at a concentration of 5 g/L, said dextran compound comprising dextran molecules having molecular weights ranging from 1 to 250 kDa (c) a physiological serum concentration of salts, and (d) nutrients for the organs, tissues and parts thereof, in a physiologically acceptable medium.

Details for Patent 7,255,983

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		2020-11-03
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2020-11-03
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2020-11-03
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2020-11-03
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2020-11-03