Claims for Patent: 10,441,611

Summary for Patent: 10,441,611

Title:	Method for producing amniotic mesenchymal stromal cell composition, method for cryopreserving the same, and therapeutic agent
Abstract:	An object of the present invention is to provide a method for producing a mesenchymal stromal cell composition, comprising conveniently and aseptically separating high-purity amnion-derived MSCs by performing enzyme treatment only once. According to the present invention, the following are provided: a method for producing a mesenchymal stromal cell composition, comprising: performing enzyme treatment of an amnion with collagenase and thermolysin and/or dispase; and filtering the enzyme-treated amnion through a mesh; a method for producing a cryopreserved mesenchymal stromal cell composition; and a therapeutic agent comprising as an active ingredient the mesenchymal stromal cell composition for a disease selected from graft-versus-host disease, inflammatory bowel disease, systemic lupus erythematosus, liver cirrhosis, or radiation enteritis.
Inventor(s):	Yamahara; Kenichi (Suita, JP), Taguchi; Akihiko (Kobe, JP), Soma; Toshihiro (Nishinomiya, JP), Ohnishi; Shunsuke (Sapporo, JP), Kobayashi; Akira (Takasago, JP)
Assignee:	NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER (Suita-shi, JP) FOUNDATION FOR BIOMEDICAL RESEARCH AND INNOVATION AT KOBE (Kobe-shi, JP) HYOGO COLLEGE OF MEDICINE (Nishinomiya-shi, JP) NATIONAL UNIVERSITY CORPORATION HOKKAIDO UNIVERSITY (Sapporo-shi, JP) KANEKA CORPORATION (Osaka-shi, JP)
Application Number:	14/912,662
Patent Claims:	1. A method for producing cultured mesenchymal stromal cells, the method comprising: preparing a mixture of mesenchymal stromal cells and a solution, wherein the mesenchymal stromal cells are mesenchymal stromal stern cells contained in a mesenchymal stromal cell composition; cryopreserving the mixture; thawing the cryopreserved mixture; and culturing the thawed mixture, thereby obtaining the cultured mesenchymal stromal cells, wherein the mesenchymal stromal cell composition comprises 20% or less of CD324-positive epithelial cells and 75% or more of CD90-positive cells, wherein the solution comprises from 5% to 10% by mass of dimethylsulfoxide, and from 5% to 10% by mass of hydroxyethyl starch or from 1% to 5% by mass of dextran. 2. The method according to claim 1, wherein the solution further comprises from more than 0% to 5% by mass of human albumin. 3. The method according to claim 1, wherein the mesenchymal stromal cell composition is obtained by a process comprising treating an amnion with an enzyme solution comprising collagenase and at least one of thermolysin and dispase. 4. The method according to claim 3, wherein the enzyme solution comprises from 50 CDU/ml to 1000 CDU/ml of the collagenase and from 100 PU/ml to 800 PU/ml of the total of the at least one of thermolysin and dispase. 5. The method according to claim 1, further comprising culturing the mesenchymal stromal cells before preparing the mixture of the mesenchymal stromal cells and the solution. 6. A method for producing a composition, comprising: diluting cultured mesenchymal stromal cells obtained by the method according to claim 1 two-fold or more with an infusion preparation. 7. A therapeutic method, comprising: administering a composition obtained by the method according to claim 6 to a patient in need thereof. 8. The therapeutic method according to claim 7, wherein the composition is injected to the patient. 9. The therapeutic method according to claim 7, wherein the therapeutic method is a method for treating at least one disease selected from the group consisting of a graft-versus-host disease, an inflammatory bowel disease, systemic lupus erythematosus, liver cirrhosis, and radiation enteritis. 10. A therapeutic method, comprising: administering the cultured mesenchymal stromal cells obtained by the method according to claim 1 to a patient in need thereof. 11. The therapeutic method according to claim 10, wherein the cultured mesenchymal stromal cells are injected to the patient. 12. The therapeutic method according to claim 10, wherein the cultured mesenchymal stromal cells are in a preparation for transplantation having a cell aggregate or sheet-like structure. 13. The therapeutic method according to claim 10, wherein the therapeutic method is a method for treating at least one disease selected from the group consisting of a graft-versus-host disease, an inflammatory bowel disease, systemic lupus erythematosus, liver cirrhosis, and radiation enteritis.

Details for Patent 10,441,611

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2033-08-19