The Kugathasan Research Team has many clinical trials that patients are actively being recruited for. These studies are used to better understand how IBD affects patients and provides a mechanism for patients to actively participate in research. The current clinical trials are below:
Develop - A Multi-center, Prospective, Long-term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease. The purpose of this study is to collect long-term safety information on the disease and medications that you received or are receiving for your inflammatory bowel disease.
Cape Registry - A long-term (10 years) post-marketing observational study to assess the safety and effectiveness of Humira (Adalimumab) in pediatrics with moderately to severely active Crohn’s Disease.
MSC Infusion (No more recruitment) – In this Phase 1 trial, the investigators intend to show safety and tolerability of autologous MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media. Fresh, non-cryopreserved, autologous MSCs will be delivered intravenously as a single bolus dose in a dose-escalation phase I study. The investigators intend to test whether the product is clinically safe in adults (18-65 years old) with CD and to determine the maximal deliverable dose. The secondary endpoint will monitor effectiveness using CDAI as an endpoint.
Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease - The primary purpose of this study is to test whether a cadre of novel blood and MRI biomarkers can distinguish fibrotic from non-fibrotic CD lesions, either individually or in combination. This will be achieved by comparing the biomarker results of stricturing CD patients undergoing small bowel resection (AIM 1) to the results of CD patients with inflammatory non-stricturing, non-penetrating lesions (AIM 2). Secondary purposes of this study are 1) to establish normative values for the novel blood-based biomarkers in healthy volunteer subjects without known bowel inflammation, and 2) to characterize and compare the fecal calprotectin and microbiota in small bowel CD patients with B1 and B2 or B3 disease as well as healthy volunteer subjects.
Mechanisms of Intestinal Inflammation following Heal Resection for Crohn's Disease: Building a biobank of data and samples to build a predictive model of disease recurrence (Ileal Post-Op Study) - The objective of this study is to identify the genetic, serological and microbial factors associated with the recurrence of inflammation following ileal resection for Crohn’s Disease (CD). This study will also investigate mechanistic pathways in disease pathogenesis.
Relation of Social Factors with Racial Disparities in Pediatric Inflammatory Bowel Disease (SaFR kids)