IP Library Granted Patent US 11,389,566
Granted Patent B2
US 11,389,566 · App. 16/085,001 · Granted Jul 19, 2022

Method and composition for treating inflammatory bowel disease

Inventors: Marc Ramer (Weston, FL); Stephen F. Badylak (Pittsburgh, PA); Timothy Keane (Wellsboro, PA)
Assignees: Regentys Corporation; University of Pittsburgh—of the Commonwealth System of Higher Education
A61L27/3633A61K35/22A61K35/38A61L27/36A61L27/3629A61L27/3679A61L27/3834A61L27/52A61L27/54A61P1/00
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,389,566
App. No.
16/085,001
Granted
Jul 19, 2022
Kind
B2
Abstract

Methods and compositions for treating diseased or damaged tissue, such as Inflammatory Bowel Disease, e.g., Ulcerative Colitis, include tissue regeneration using stem cells or tissue grafts which stimulate stem cell migration to the damaged tissue. The tissue grafts can be extracellular matrix (ECM) material, such as tissue-specific extracellular matrix (TS-ECM). The methods can also include mucosal resection of the damaged or diseased tissue prior to placement of the graft.

Claims (13)

1. A method for treating Inflammatory Bowel Disease (IBD) in a patient, said method comprising the steps of:

providing an extracellular matrix hydrogel (ECMH) composition derived from tissue selected from the group consisting of large intestine, small intestine submucosa (SIS), and urinary bladder matrix (UBM), wherein the ECMH composition is a reverse thermal gel reconstituted from a lyophilized digest solution, wherein the ECMH composition is at a concentration which exhibits mucoadhesion in diseased tissue equivalent to mucoadhesion in healthy tissue and forms a barrier having a residence time up to 24 hours; and

applying or administering the ECMH composition to intestinal tissue of the patient exhibiting IBD to induce in situ replacement of diseased or damaged tissue with healthy lower intestinal tissue.

2. The method of claim 1 , wherein the IBD is selected from Ulcerative Colitis and Crohn's Disease.

3. The method of claim 2 wherein the application or administration of the ECMH composition stimulates migration of stem cells to the colon tissue, wherein the stem cells develop in situ to effect reconstructive tissue remodeling of the colon mucosal tissue exhibiting Ulcerative Colitis or Crohn's Disease.

4. The method of claim 1 wherein the ECMH composition is prepared as a fluidized gel, solution, or suspension.

5. The method of claim 1 wherein the ECMH is a solution or suspension administered by enema.

6. The method of claim 1 wherein the ECMH is a solution or suspension administered endoscopically.

7. The method of claim 1 wherein, prior to the application or administration step b), the method further comprises resecting or ablating diseased or damaged colon mucosal tissue.

8. The method of claim 7 wherein the resecting step comprises endoscopic mucosal resection (EMR) or ablation using EDTA.

9. The method of claim 1 , wherein the method further comprises the optional steps selected from the group consisting of:

creating an ileostomy in the patient, and

feeding the patient intravenously using Total Parenteral Nutrition while new colon mucosa forms or develops.

Assignments (4)
CHANGE OF NAME Recorded Dec 27, 2018
From: ASANA MEDICAL, INC.
To: REGENTYS CORPORATION
Reel/Frame 049057/0849 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 14, 2018
From: RAMER, MARC
To: ASANA MEDICAL, INC.
Reel/Frame 046882/0892 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 14, 2018
From: BADYLAK, STEPHEN F
To: UNIVERSITY OF PITTSBURGH -OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
Reel/Frame 046882/0952 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 14, 2018
From: KEANE, TIMOTHY
To: UNIVERSITY OF PITTSBURGH -OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
Reel/Frame 046882/0955 →
Continuity (2)
Provisional Application 62308102 · Mar 14, 2016
Related Publication 20190076574A1 · Mar 14, 2019
Cited By (4)
US 12,263,270 US 12,383,243 US 12,605,489 US 12,734,274