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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of pending U.S. Patent Application, Ser. No. 15 / 085,001, filed Sep. 14, 2018, which is a 371 filing from expired International Application No. PCT / US2017 / 022363 filed Mar. 14, 2017, and claiming the benefit of expired U.S. Provisional Patent Application, Ser. No. 62 / 308,102 filed Mar. 14, 2016.[0002]This application is also a continuation-in-part of pending U.S. patent application Ser. No. 15 / 343,138, filed Nov. 3, 2018, which is a continuation of abandoned U.S. Patent Application, Ser. No. 14 / 782,887, filed Oct. 7, 2015, which is a 371 filing from expired International Application No. PCT / US2014 / 033365 filed Apr. 8, 2014, and claims the benefit of expired U.S. Provisional Patent Applications, Ser. No. 61 / 901,237 filed Nov. 7, 2013, Ser. No. 61 / 843,286 filed Jul. 5, 2013, and Ser. No. 61 / 809,606 filed Apr. 8, 2013.BACKGROUND[0003]Inflammatory Bowel Disease (IBD) consists of two independent diseases: Croh...

AI Technical Summary

Benefits of technology

[0018]A preferred TS-ECM is derived from not only the same type of tissue (i.e., colon-derived ECM for colon tissue treatment), but is also derived from the same species as the species being treated. For example, treatment of UC in a human will employ human colon mucosal tissue as the TS-ECM scaffold composition. The tissue graft can be an allograft or xenograft. Reciprocal exchange of stimuli and information (known and referred to in the art as “dynamic reciprocity”) can exist between ECM and cells, providing an advantage for using ECM grafts. This dynamic reciprocity can be facilitated or improved by the use of TS-ECM grafts.

[0020]In one embodiment, the tissue graft composition can be an ECM scaffold formed as a solid sheet or tube which can be placed or secured onto the colon mucosa. A solid sheet or tube scaffold can be implanted or transplanted or, as recognized in the art, affixed, applied, or attached, at a desired site in a patient by mechanical or surgical means, including but not limited to sutures, staples, stents, or clips, or can be adhered to the mucosa by an acceptable adhesive, such as a pharmaceutically acceptable or therapeutically acceptable adhesive, including a bioadhesive. One preferred procedure for delivering an ECM composition to the colon can employ an endoscope, which can advantageously minimize invasive surgical procedures.

[0046]Extracellular Matrix (ECM), or Extracellular Matrix Hydrogel (ECMH, i.e. ECM in liquid or fluid, gellable form) can also be useful in the treatment or prevention of diseases or conditions that are not autoimmune related, such as rectal mucositis, which can present in patients undergoing radiation or chemotherapy. For example, ECMH therapy, e.g., administering ECMH by enema before radiation or chemotherapy treatments are initiated, and continuing ECMH administration throughout the course of such radiation or chemotherapy can prevent the onset of rectal mucositis in the patient.

Problems solved by technology

However, overly-purified, chemically modified or synthetic materials can lead to adverse immune responses by the host and limit cell migration into the matrix.

However, many of these scaffolds are derived from non-human tissue, and none have been described for use in the treatment or regeneration of lower intestine tissue, such as colon tissue, and not specifically for the treatment of UC.

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