Claims for Patent: 8,288,085

Summary for Patent: 8,288,085

Title:	Method of separating pancreatic islet
Abstract:	The present invention provides a pancreatic islet isolation method comprising the steps of (1) injecting a protection solution containing a protease inhibitor into the pancreatic duct of an procured pancreas; (3) digesting the pancreas into which the protection solution has been injected; and (4) purifying the digested pancreatic tissue using a purification solution containing a density gradient reagent. The present invention also provides a protection solution for injection into the pancreatic duct, a pancreas preservation solution for the two-layer method, and an islet purification solution.
Inventor(s):	Matsumoto; Shinichi (Kyoto, JP), Wada; Hiromi (Kyoto, JP), Noguchi; Hirofumi (Kyoto, JP)
Assignee:	Kyoto University (Kyoto-shi, Kyoto, JP)
Application Number:	11/793,679
Patent Claims:	1. A pancreatic islet isolation method comprising the sequential steps of: (1) injecting a protection solution containing a protease inhibitor and approximately 4 to 50 mmol/L of potassium into the pancreatic duct of a procured pancreas, wherein said protease inhibitor is at least one selected from the group consisting of ulinastatin, gabexate mesilate and nafamostat mesilate; (2) preserving said pancreas into which the protection solution has been injected by a two-layer method that comprises introducing (i) a liquid perfluorocarbon and (ii) a preservation solution containing a protease inhibitor, approximately 4 to 50 mmol/L of potassium, and 80 to 160 mmol/L of trehalose into a container and forming two layers, feeding oxygen into the container, and preserving said pancreas in said container; (3) injecting a collagenase solution into said pancreas into which the protection solution has been injected and digesting the pancreas; and (4) purifying the digested pancreatic tissue using a purification solution containing a density gradient reagent wherein said density gradient reagent is Ficoll solution or iodixanol. 2. The isolation method according to claim 1, wherein the protection solution is injected into the pancreatic duct in an amount of approximately 0.1 to 10 ml per 1 gram organ weight in step (1). 3. The isolation method according to claim 1, wherein the purification solution in step (4) further contains trehalose. 4. The isolation method according to claim 1, wherein the density gradient reagent in step (4) is iodixanol. 5. The isolation method according to claim 1, wherein the purification solution in step (4) further contains a protease inhibitor. 6. The method according to claim 1, wherein in step (1) said protease inhibitor is ulinastatin. 7. The method according to claim 1, wherein in step (1) said protease inhibitor is gabexate mesilate. 8. The method according to claim 1, wherein in step (1) said protease inhibitor is nafamostat mesilate.

Details for Patent 8,288,085

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2024-12-22