Method and composition for treating inflammatory bowel disease

Abstract

Methods and compositions for treating diseased or damaged tissue, such as Inflammatory Bowel Disease, e.g., Ulcerative Colitis, include tissue regeneration extracellular matrix hydrogel (ECMH) which stimulates 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.

1 . A method for treating, ameliorating, or curing Inflammatory Bowel Disease, said method comprising applying an extracellular matrix hydrogel (ECMH) composition to lower intestinal tract tissue diseased or damaged by the Inflammatory Bowel Disease, wherein the ECMH provides reconstructive tissue remodeling of the diseased or damaged tissue to treat, ameliorate, or cure the Inflammatory Bowel Disease. 
     
     
         2 . The method of  claim 1  wherein the ECMH is derived from tissue selected from small intestine, large intestine, and urinary bladder. 
     
     
         3 . The method of  claim 2  wherein the ECMH is derived from Small Intestine Submucosa (SIS) tissue. 
     
     
         4 . The method of  claim 1  wherein the ECMH is prepared for delivery as a fluid selected from a solution, suspension, and gel. 
     
     
         5 . The method of  claim 1  wherein the ECMH is a thermoreversible gel. 
     
     
         6 . The method of  claim 5  wherein the thermoreversible ECMH is mucoadhesive. 
     
     
         7 . The method of  claim 6  wherein the thermoreversible mucoadhesive gel has a residence time of at least two hours. 
     
     
         8 . The method of  claim 6  wherein the thermoreversible mucoadhesive gel has an intestinal residence time of up to 48 hours. 
     
     
         9 . The method of  claim 6  wherein the thermoreversible mucoadhesive gel has a residence time of between 2 hours to 48 hours. 
     
     
         10 . The method of  claim 6  wherein the thermoreversible mucoadhesive gel has an intestinal residence time of between 2 hours and 24 hours. 
     
     
         11 . The method of  claim 6  wherein the thermoreversible mucoadhesive gel has an intestinal residence time of between 2 hours and 12 hours. 
     
     
         12 . The method of  claim 6  wherein the thermoreversible mucoadhesive gel forms a barrier layer over the lower intestinal tract tissue diseased or damaged by the Inflammatory Bowel Disease. 
     
     
         13 . The method of  claim 1  wherein the ECMH is delivered endoscopically. 
     
     
         14 . The method of  claim 1  wherein the ECMH is delivered by enema. 
     
     
         15 . The method of  claim 1  wherein the lower intestinal tissue is diseased or damaged as a result of Crohn's Disease, Ulcerative Colitis, familial adenomatous polyposis, Hirschsprungs, stricture, proctitits, rectal mucositis, colon or rectal cancer, or fistula. 
     
     
         16 . The method of  claim 1  wherein the Inflammatory Bowel Disease is selected from the group consisting of Crohn's Disease and Ulcerative Colitis. 
     
     
         17 . The method of  claim 1  wherein the Inflammatory Bowel Disease is Crohn's Disease. 
     
     
         18 . The method of  claim 1  wherein the Inflammatory Bowel Disease is Ulcerative Colitis. 
     
     
         19 . The method of  claim 1  wherein the method further comprises mucosal resection of the damaged or diseased tissue prior to application of the ECMH.