Claims for Patent: 9,963,679

Summary for Patent: 9,963,679

Title:	Cultured pancreas islets
Abstract:	Methods of preparing pancreatic islets that may comprise pancreatites are provided. The methods may involve subjecting a pancreas and/or pieces thereof to disruption, such as, for example, an enzyme digest, and seeding the recovered cellular product comprising islets in a culture medium comprising at least a detectable amount of endocrine tissue and/or exocrine tissue.
Inventor(s):	Taylor; Michael J. (Mt. Pleasant, SC), Baicu; Simona C. (Charleston, SC)
Assignee:	LIFELINE SCIENTIFIC, INC. (Itasca, IL)
Application Number:	13/278,492
Patent Claims:	1. A method of preparing pancreatic islets, comprising: culturing pancreatic islets obtained from a donor pancreas ex vivo in the presence of a donor tissue material in a culturing medium comprising at least a detectable amount of acinar tissue obtained from the donor pancreas; wherein the donor tissue material is produced by distending and dissociating a pancreas or pancreas tissue by ductal infusion of a collagenase enzyme, and the islets are dispersed in the culture medium, and the islets are present in an amount less than about 70% and greater than about 20% of the total area of the acinar tissue and an endocrine tissue present in the culture medium, the amount of islets being calculated by the ratio of the area encompassed by the islets to the total area of acinar tissue and endocrine tissue present in the culture medium; and forming pancreatites in the culture medium via aggregation of the acinar tissue and the dispersed islets; wherein the islets were obtained from a donor selected from the group consisting of a non-adult donor and a juvenile donor, the islets comprise immature islets, and the culture medium is present on a gas permeable membrane. 2. The method of claim 1, further comprising isolating the islets from pancreas tissue by treating the pancreas tissue with a digestive enzyme. 3. The method of claim 1, wherein the culture medium is present in a polycarbonate gas permeable silicone membrane culture flask. 4. The method of claim 1, wherein the islets were obtained from a juvenile donor. 5. The method of claim 1, wherein the donor tissue material is obtained from a donor pancreas that was not the source of the islets. 6. The method of claim 1, wherein the donor tissue material and the islets are obtained from a single donor pancreas. 7. The method of claim 2, wherein after the islets are isolated from the pancreas tissue, the islets are combined with the donor tissue material. 8. The method of claim 7, wherein the donor tissue material and the islets are obtained from a single donor pancreas. 9. A method for preparing pancreatites, comprising: treating donor tissue comprising pancreatic islets via digestion with an enzyme to obtain cellular product comprising islets and a detectable amount of exocrine tissue comprising acinar tissue; seeding the cellular product comprising the islets and the detectable amount of exocrine tissue comprising acinar tissue into a culture medium to form a culture medium comprising dispersed islets; wherein the islets are present in an amount less than about 60% and greater than about 20% of the total area of acinar tissue and endocrine tissue present in the culture medium, the amount of islets being calculated by the ratio of the area encompassed by the islets to the total area of acinar tissue and endocrine tissue present in the culture medium; aggregating the exocrine tissue and the dispersed islets to form pancreatites in the culture medium; wherein the islets were obtained from a donor selected from the group consisting of a non-adult donor and a juvenile donor, the islets comprise immature islets, and the culture medium is present on a surface of a gas permeable membrane. 10. The method of claim 9, wherein the pancreatites comprise endocrine cells and exocrine cells. 11. The method of claim 9, wherein the surface of a gas permeable membrane is a silicone membrane of a polycarbonate gas permeable silicone membrane culture flask.

Details for Patent 9,963,679

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2030-10-22