Ecm hydrogel for treating esophageal inflammation

Patent metadata

Field	Value
Publication number	US-2026053850-A1
Application number	US-202519189024-A
Country	US
Kind code	A1
Filing date	Apr 24, 2025
Priority date	Mar 2, 2017
Publication date	Feb 26, 2026
Grant date	—

Abstract

Methods are disclosed for inhibiting esophageal inflammation in a subject, that include administering to the esophagus of the subject with esophageal inflammation a therapeutically effective amount of an extracellular matrix (ECM) hydrogel. Methods are also disclosed for reducing esophageal stricture. Compositions are disclosed that include an esophageal extracellular matrix (ECM) hydrogel.

First claim

1 - 32 . (canceled)

33 . A method for treating or inhibiting esophageal inflammation or reducing esophageal stricture in a subject in need thereof comprising:
administering topically to the lumen of the esophagus of the subject a therapeutically effective amount of (i) an extracellular matrix (ECM) hydrogel, or (ii) an ECM digest solution comprising a hydrated, decellularized, enzymatically digested ECM, wherein the ECM has not been cross-linked or dialyzed, wherein the ECM digest solution has a pH of about 7.2 to about 7.8 and forms a gel when warmed to a temperature greater than 25° C., wherein the ECM digest solution forms a hydrogel when administered to the esophagus; wherein the ECM hydrogel or ECM digest solution coats the surface of the esophagus, thereby inhibiting esophageal inflammation or reducing esophageal stricture in the subject.

34 . The method of claim 33 , where the ECM hydrogel is administered to the subject.

35 . The method of claim 34 , wherein the ECM hydrogel comprises the following characteristics:
(a) a time to 50% gelation of about 30 minutes or less at a temperature of about 37° C.; (b) a flow viscosity suitable for infusion onto the esophagus; and (c) a stiffness of about 10 to about 300 Pascal (Pa).

36 . The method of claim 34 , wherein the ECM hydrogel is produced by:
(a) solubilizing decellularized ECM by digestion of the decellularized ECM with an acid protease in an acidic solution to produce an ECM digest solution; and (b) raising the pH of the ECM digest solution to a pH between 7.2 and 7.8 to produce a neutralized digest solution, wherein the neutralized digest solution forms the ECM hydrogel when warmed to a temperature of about 37° C.

37 . The method of claim 33 , wherein the ECM digest solution is administered to the subject and forms a hydrogel when administered to the esophagus.

38 . The method of claim 37 , wherein the ECM digest solution is produced by:
(a) solubilizing decellularized ECM by digestion of decellularized ECM with an acid protease in an acidic solution to produce an ECM digest solution; and (b) raising the pH of the ECM digest solution to a pH between 7.2 and 7.8 to produce a neutralized ECM digest solution.

39 . The method of claim 37 , wherein the ECM digest solution is (i) terminally sterilized; and/or (ii) forms a gel when warmed to about 37° C.

40 . The method of claim 37 , wherein the ECM digest solution is administered to the subject and is maintained at or below 25° C. prior to administration to the subject.

41 . The method of claim 33 , wherein the ECM in the ECM hydrogel or ECM digest solution
(i) is from pig, cow, or sheep and/or (ii) is derived from urinary bladder, intestine, liver, esophagus, or dermis.

42 . The method of claim 33 , wherein the ECM in the ECM hydrogel or ECM digest solution is derived from esophagus.

43 . The method of claim 33 , wherein the ECM hydrogel or ECM digest solution is administered to the subject's esophagus orally by swallowing or gavage, by endoscopy, or by catheter.

44 . The method claim 33 , wherein ECM is present in the ECM digest solution or ECM hydrogel at a concentration of about 2 mg/mL to about 20 mg/mL.

45 . The method claim 33 , wherein the subject has Barrett's esophagus or is at risk of Barrett's esophagus.

46 . The method of claim 33 , wherein the method inhibits or reverses development of esophageal neoplasia in the subject.

47 . The method of claim 33 , wherein the method restores the epithelial barrier in the esophagus of the subject.

48 . The method of claim 33 , wherein the method reduces esophageal stricture in the subject.

49 . The method of claim 33 , wherein the method treats or inhibits inflammation in the esophagus of the subject.

50 . The method of claim 33 , wherein the subject has gastroesophageal reflux disease (GERD).

51 . The method of claim 33 , wherein the method inhibits development of esophageal adenocarcinoma in the subject.

52 . The method of claim 33 , wherein the topical administration of the ECM hydrogel or ECM digest solution coats the esophageal mucosa and does not invade the underlying submucosa.

Assignees

• Univ Pittsburgh Commonwealth Sys Higher Education

Inventors

• Badylak Stephen Francis
• Naranjo Gutierrez Juan Diego
• Saldin Lindsey Tamiko

Classifications

• A61K9/06

  Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} · CPC title

• A61P1/04 Primary

  for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants · CPC title

• A61K35/12 Primary

  Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00) · CPC title