IP Library › Granted Patent US 12,383,243
Granted Patent B2
US 12,383,243 · App. 17/581,591 · Granted Aug 12, 2025

Extracellular matrix (ECM) hydrogel as a submucosal fluid cushion

Inventors: Stephen Francis Badylak (West Lafayette, IN); Lindsey Tamiko Saldin (El Segundo, CA); Juan Diego Naranjo Gutierrez (Manizales, CO)
Assignee: University of Pittsburgh—Of the Commonwealth System of Higher Education
A61B17/00234A61L27/3633A61L27/3687A61L27/52A61B2017/00269A61L2400/06
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Quick Facts
Patent No.
US 12,383,243
App. No.
17/581,591
Granted
Aug 12, 2025
Kind
B2
Abstract

Methods are disclosed for dissecting a mucosa and a submucosa from a muscularis propria from a region of an organ of a subject, wherein the organ is not the esophagus. In some embodiments, the organ is in the gastrointestinal tract. These methods include injecting submucosally into the organ of the subject a pharmaceutical composition comprising an extracellular matrix (ECM) hydrogel to form a cushion between the submucosa and the underlying muscularis propria at the region of the organ, wherein the ECM hydrogel has the following characteristics: a) a time to 50% gelation of less than 30 minutes at a temperature of about 37° C.; b) a flow viscosity suitable for infusion into the organ; and c) a stiffness of about 10 to about 400 Pascal (Pa).

Claims (34)

1. A method for dissecting a mucosa and a submucosa from a muscularis propria from a region of an organ of a subject, comprising:

injecting submucosally into the organ of the subject a pharmaceutical composition comprising an extracellular matrix (ECM) hydrogel to form a cushion between the submucosa and the underlying muscularis propria at the region of the organ, thereby dissecting the mucosa and the submucosa from the underlying muscularis propria and inhibiting inflammation in the region of the organ in the subject, wherein the organ is not the esophagus, and wherein the ECM hydrogel has the following characteristics:

a) a time to 50% gelation of less than 30 minutes at a temperature of about 37° C.;

b) a flow viscosity suitable for infusion into the organ;

c) a stiffness of about 10 to about 400 Pascal (Pa); and

d) an ECM concentration of about 8 mg/ml to about 20 mg/ml.

2. The method of claim 1 , wherein the time to 50% gelation is less than 20 minutes at a temperature of about 37° C.

3. The method of claim 1 , wherein the time to 50% gelation is about 3 to about 10 minutes.

4. The method of claim 1 , wherein the flow viscosity is about 0.1 to about 100 Pa*s at a shear rate of about 0.1/s and is about 0.01 to about 0.2 Pa*s at a shear rate of 1000/s.

5. The method of claim 1 , wherein the flow viscosity is about 0.1 to about 30 Pa*s at a shear rate of 1/s, and is about 0.02 to about 0.8 Pa*s at a shear rate of about 100/s.

6. The method of claim 1 , wherein the ECM hydrogel has a stiffness of 10-300 Pa.

7. The method of claim 1 , wherein the ECM hydrogel is an esophageal ECM hydrogel.

8. The method of claim 1 , wherein the ECM concentration in the hydrogel is about 8 mg/ml to about 16 mg/ml.

9. The method of claim 1 , wherein the ECM hydrogel is administered endoscopically or via a catheter.

10. The method of claim 1 , wherein the ECM hydrogel is produced by

(a) solubilizing decellularized extracellular matrix (ECM) by digestion with an acid protease in an acidic solution to produce digested ECM; and

(b) raising the pH of the digested ECM to a pH between 7.2 and 7.8 to produce a neutralized digest solution.

11. The method of claim 10 , wherein (b) raising the pH of the digested ECM comprises adding a base or an isotonic buffer to raise the pH of the digested ECM.

12. The method of claim 10 , wherein the acid protease is pepsin, trypsin or a combination thereof.

13. The method of claim 1 , wherein the ECM hydrogel is maintained at or below 25° C. prior to administration to the subject.

14. The method of claim 1 , wherein the ECM hydrogel is injected endoscopically or via a catheter.

15. The method of claim 1 , wherein the ECM hydrogel is prepared from ECM derived from urinary bladder, small intestine, dermis, kidney, or liver.

16. The method of claim 1 , wherein the organ is the colon, stomach, cecum, sigmoid colon, rectum, small intestine or large intestine.

17. The method of claim 16 , wherein the organ is the colon and the method comprises dissecting the mucosa and the submucosa from the colon.

18. The method of claim 16 , wherein the organ is the colon, and wherein the method comprises dissecting a polyp or a carcinoma from the colon.

19. The method of claim 1 , wherein the organ is the stomach, small intestine or large intestine, and the method comprises a method of dissecting an adenocarcinoma or carcinoma from the organ.

20. The method of claim 1 , further comprising performing an endoscopic resection procedure on the cushion to remove the dissected mucosa and submucosa.

21. The method of claim 20 , wherein the resection procedure is an endoscopic mucosal resection or an endoscopic submucosal dissection.

22. The method of claim 21 , wherein the method comprises:

dividing the cushion such that hydrogel is retained on the underlying muscularis propria of the organ and the mucosa and the submucosa are removed from the region of the organ.

23. The method of claim 1 , wherein the subject is human.

24. The method of claim 1 , wherein the organ is in the gastrointestinal tract.

25. The method of claim 24 , wherein the organ is selected from duodenum, stomach, small intestine, colon or rectum.

26. The method of claim 1 , wherein the method of dissecting comprises endoscopic mucosal resection or endoscopic mucosal dissection.

Assignments (2)
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY'S NAME FRANIS BADLAK PREVIOUSLY RECORDED AT REEL: 058731 FRAME: 0024. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 17, 2022
From: BADYLAK, STEPHEN FRANCIS; SALDIN, LINDSEY TAMIKO; NARANJO GUTIERREZ, JUAN DIEGO
To: UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
Reel/Frame 061203/0671 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 21, 2022
From: BADYLAK, FRANCIS FRANCIS; SALDIN, LINDSEY TAMIKO; NARANJO GUTIERREZ, JUAN DIEGO
To: UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
Reel/Frame 058731/0024 →
Continuity (3)
Continuation 17254040
Provisional Application 62688198 · Jun 21, 2018
Related Publication 20220354473A1 · Nov 10, 2022
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