IP Library Granted Patent US 10,729,813
Granted Patent B2
US 10,729,813 · App. 16/593,232 · Granted Aug 4, 2020

Extracellular matrix-derived gels and related methods

Inventors: Stephen F. Badylak (West Lafayette, IN); Donald Freytes (Pittsburgh, PA)
Assignee: University of Pittsburgh—Of the Commonwealth System of Higher Education
A61L27/3633A61K35/12A61L27/34A61L27/3687A61L27/38A61L27/52A61L27/54C12P21/06A61K38/00A61L2300/64A61L2400/06A61L2420/04
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Quick Facts
Patent No.
US 10,729,813
App. No.
16/593,232
Granted
Aug 4, 2020
Kind
B2
Abstract

Provided are methods for preparing gelled, solubilized extracellular matrix (ECM) compositions useful as cell growth scaffolds. Also provided are compositions prepared according to the methods as well as uses for the compositions. In one embodiment a device, such as a prosthesis, is provided which comprises an inorganic matrix into which the gelled, solubilized ECM is dispersed to facilitate in-growth of cells into the ECM and thus adaptation and/or attachment of the device to a patient.

Claims (31)

1. A composition comprising:

an acidic solution comprising an acid protease and solubilized, non-dialyzed, non-crosslinked extracellular matrix from a tissue selected from the group consisting of heart, pancreas, liver, ovary, spleen, and urinary bladder removed of submucosa;

wherein, the acidic solution, when neutralized, forms a gel at a temperature greater than 25° C.

2. The composition of claim 1 , wherein the ECM is from heart tissue.

3. The composition of claim 1 , wherein the ECM is from liver tissue.

4. The composition of claim 1 , wherein the acid protease is pepsin.

5. The composition of claim 1 , wherein the solution is frozen.

6. The composition of claim 1 , wherein the solution has a pH of about 2.

7. A composition comprising:

a hydrogel comprising solubilized, non-dialyzed, non-crosslinked extracellular matrix (ECM) and an acid protease, the hydrogel having a pH in the range of 7.2 to 7.8.

8. The composition of claim 7 , wherein the acid protease is pepsin.

9. The composition of claim 7 , wherein the ECM is derived from a tissue selected from intestine, urinary bladder, liver, esophagus, pancreas, dermis, heart, ovary, or spleen.

10. The composition of claim 9 , wherein the ECM is derived from heart.

11. The composition of claim 9 , wherein the ECM is derived from liver.

12. The composition of claim 7 , wherein the pH is in the range of 7.2 to 7.4.

13. A method of preparing an extracellular matrix-derived gel comprising:

neutralizing an acidic solution comprising solubilized, digested, non-dialyzed, non-crosslinked extracellular matrix (ECM) and an acid protease to produce a neutralized solution, wherein the neutralized solution produces a hydrogel at a temperature greater than 25° C.

14. The method of claim 13 , wherein the neutralized solution has a pH in the range of 7.2 to 7.8.

15. The method of claim 13 , wherein the acid protease is pepsin.

16. The method of claim 13 , wherein the hydrogel forms after 40 minutes at 37° C.

17. The method of claim 13 , wherein the ECM is derived from a tissue selected from intestine, urinary bladder, liver, esophagus, pancreas, dermis, heart, ovary, or spleen.

18. A method of preparing a gelable extracellular matrix composition comprising:

solubilizing non-dialyzed, non-crosslinked extracellular matrix (ECM) in an acidic solution with an acid protease to produce an acidic solution of solubilized, digested, non-dialyzed, non-crosslinked ECM and the acid protease;

wherein, upon neutralizing the acidic solution to produce a neutralized solution having a pH of between 7.2 to 7.8, the solution forms a gel at a temperature greater than 25° C.

19. The method of claim 18 , wherein the ECM is from a tissue selected from the group consisting of intestine, urinary bladder, liver, esophagus, pancreas, dermis, heart, ovary, and spleen.

20. The method of claim 19 , wherein the ECM is from heart tissue.

21. The method of claim 19 , wherein the ECM is from liver tissue.

22. The method of claim 18 , wherein the acid protease is pepsin.

23. The method of claim 18 , wherein the ECM is lyophilized or dried, and then comminuted prior to solubilizing in the acidic solution.

24. The method of claim 18 , wherein the ECM is solubilized by stirring in the acidic solution at room temperature.

25. The method of claim 18 , wherein the pH of the acidic solution is about 2.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 4, 2019
From: BADYLAK, STEPHEN F.; FREYTES, DONALD
To: UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
Reel/Frame 050627/0076 →
Continuity (7)
Continuation 16288831 · Feb 28, 2019
Continuation 15996916 · Jun 4, 2018
Continuation 14182791 · Feb 18, 2014
Division 13684830 · Nov 26, 2012
Continuation 12040140 · Feb 29, 2008
Provisional Application 60892699 · Mar 2, 2007
Related Publication 20200030493A1 · Jan 30, 2020
Cited By (6)
US 12,263,270 US 12,303,533 US 12,318,505 US 12,383,243 US 12,605,489 US 12,734,274