PI: Stephen Badylak

Title: Extracellular Matrix as a Therapy for Inflammatory Bowel Disease

Description: Clinical Problem: Inflammatory Bowel Disease (IBD) affects nearly 1.5 million Americans with approximately 70,000 new cases diagnosed each year. There are a number of forms of IBD most notably ulcerative colitis (UC) and Crohn’s disease, but the medical device therapy described in this work could also address proctitis, proctosigmoiditis, and rectal mucositis. UC is the initial research target that may or may not include the other forms of inflammatory disease in the colon. UC significantly increases the risk of developing colorectal cancer and negatively impacts quality of life. The etiology of UC is unknown but altered intestinal barrier function and production of cytotoxic effector molecules within the mucosal lining of the colon are known to play central roles in the development of UC. The proposed work would investigate and evaluate the ability of a hydrogel form of extracellular matrix (ECM) to restore structure and function of the mucosal lining of the colon in a preclinical UC model. These findings would represent an important contribution to required regulatory filings prior to human studies.

Objective: To determine whether ExtraCellular Matrix Hydrogel (ECMH) derived from porcine small intestinal submucosa can (1) mitigate the inflammatory effects in a UC animal model and (2) provide a scaffold for healing of damaged mucosal tissue in an animal model.

Hypothesis: Decellularized xenogeneic (porcine) ECMH delivered enterically via catheter to rats with experimentally induced ulcerative colitis will mitigate the severity and duration of the inflamed tissue in the colon and provide a scaffold for healing of damaged mucosal tissue.

Research Plan:

  • The research plan is designed to address the following questions:
  • Can an ECMH product be consistently produced and characterized at lab scale?
  • Can ECMH scaffold facilitate the colonic mucosa healing in a colitic rat model?
  • What are the physical properties of ECMH?
  • Does an ECMH scaffold potentially influence native cellular properties?

I. Study #1: To demonstrate the ability to successfully produce ECMH.

II. Study #2: To characterize the temporal host response and downstream remodeling outcomes following DSS-induced colitis with and without catheter-based ECMH treatment (enema) in a rat model.

III. Study #3: To characterize the ECM hydrogels.

IV. Study #4: To characterize the cellular response to ECMH in-vitro (after successful completion of Study #1-3).

Source: Asana Medical Inc.
Term: 6/1/2015-5/31/2017
Amount: $393,417