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  • A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PURSUIT 2) Rochester, Minn.

    The purpose of this study is to evaluate effectiveness of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

  • A Phase I study of intra-arterial delivery of mesenchymal stem cells for luminal Ulcerative Colitis (MSC UC) Rochester, Minn.

    Ulcerative Colitis (UC) is a chronic inflammatory disease affecting the mucosal lining of the colon and rectum and the incidence is increasing, but the etiology remains unknown. Patients may require a proctocolectomy due to refractory disease. Prior to an operation, UC is treated with antibiotic therapy, immunomodulatory therapy and immunosuppressive agents. While there is an increasing number of approved biologics for the treatment of UC, there are many patients that still suffer from refractory disease. Thus, alternative mechanisms of therapy are desperately needed.

    Treatments that have the potential to reduce mucosal inflammation could alleviate the pathology of luminal UC. This trial will use arterially delivered mesenchymal stem cells (MSCs) to produce these regenerative signals allowing for mucosal healing. This study will enroll patients with medically refractory moderate to severe inflammatory UC who are or plan to be scheduled for a colectomy. Patients enrolled will be those who failed all attempts at standard treatment including antibiotics, corticosteroids, immunomodulator, and/or biologic therapy.

    Participants will undergo screening for study, if eligible, participants will be dosed with 15 million or 30 million cells will be administered via IA delivery with interventional radiology. Participant study visits after study intervention includes visits on: Day 1, Week 1, Week 2, Week 8, Week 24, Week 52, and Week 104.

  • A Pilot Study of a Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy Rochester, Minn.

    This investigation constitutes an initial evaluation of the stoma occlusion device in humans with a mature permanent Brooke ileostomy. The overall objective of this study is to assess feasibility and initial operating characteristics of a novel stoma occlusion device. The study will recruit 20 patients for placement of the device into the mature Brooke ileostomy and subsequent 2 hour observation period. The device will remain in the ileostomy for up to 2 hours.

  • Mayo Clinic Inflammatory Bowel Disease Repository (Mayo Clinic Inflammatory Bowel Disease Repository) Scottsdale/Phoenix, Ariz., Jacksonville, Fla., Rochester, Minn.

    The purpose of this research study is to collect clinical information and human samples from patients with IBD. The data collected will be used to create an organized, accessible resource of human samples for biological research in IBD.

  • Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients with Ulcerative Colitis (PROPHETIC Study) (PROPHETIC Study) Rochester, Minn.

    This study seeks to identify predictive fecal, blood, and tissue biomarkers, in which biomarkers can be used to identify responders that will be reflective of disease severity or predict response to Janus Kinase Inhibitor Therapy. The benefits to the sub-study are to develop a population PK/PD model to characterize the relationships between local and systemic drug exposure and clinical, endoscopic, histologic, or biologic response to therapy.  Study also seeks to collect safety data from these subjects on Janus Kinase Inhibitor Therapy.

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  • Understanding and Curing Crohn’s Disease Requires an Epigenetic Approach Rochester, Minn.

    The purpose of this study is to collect clinical information, blood and tissue samples from people with Crohn’s disease at the time of their bowel resection and at their standard of care colonoscopy after bowel resection. People without Crohn’s Disease are being asked only to give tissue samples at the time of a clinically indicated colonoscopy so their tissue can be compared to those that have Crohn’s Disease.

    This study will compare the genetic codes (DNA) from active disease affected intestinal cells to these same cells from the same patient when they are without disease (inactive). We will be able to conclude which genetic codes are modified in the setting of active and inactive CD. This study has hopes of understanding the root cause of Crohn’s Disease.

Closed for Enrollment

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