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Helmsley Grants $4.3 Million to Develop Tools for the Clinical Testing of Anti-fibrotic Treatments for Crohn’s Disease Patients

Cleveland Clinic, Mayo Clinic, and Robarts Clinical Trials will collaborate to address a critical unmet treatment need for people with Crohn’s disease

New York, NY – April 15, 2019 – The Leona M. and Harry B. Helmsley Charitable Trust has awarded $4.3 million to Cleveland Clinic, Mayo Clinic, and Robarts Clinical Trials, Inc. to launch the Stenosis Therapy and Anti-Fibrotic Research (STAR) consortium for the development of imaging and patient-reported outcome tools that will enable the clinical testing of new anti-fibrotic therapies for Crohn’s disease patients.

People with Crohn’s disease, a chronic inflammatory condition of the intestinal tract, frequently develop stricturing or narrowing of the intestinal tract due to excessive scar tissue formation, known as fibrosis. Although advances have been made in the treatment of gut inflammation, the development of treatments for Crohn’s disease fibrosis has been hindered due to a lack of appropriate tools that enable clinical testing of anti-fibrotic drugs.

The STAR consortium, for which Cleveland Clinic will be the coordinating center, will be co-led by Florian Rieder, M.D., Cleveland Clinic, Joel Fletcher, M.D., Mayo Clinic and Brian Feagan M.D., Robarts Clinical Trials, Inc. The consortium will draw upon the expertise of each of the centers to develop and validate a patient-report outcome tool that measures signs, symptoms and impacts experienced by stricturing Crohn’s disease patients that are indicative of a therapy’s success or failure, as well as an imaging system to measure how these strictures respond to anti-fibrotic therapies.

“Addressing the unmet medical needs of patients with Crohn’s disease is at the center of our Program’s mission. The STAR consortium represents a tremendous opportunity to create the tools necessary for advancing anti-fibrotic therapeutic clinical trials,” said Dr. Garabet Yeretssian, Director of the Helmsley Charitable Trust’s Crohn’s Disease Program. “Helmsley is proud to partner with the STAR consortium experts to develop and disseminate these tools to the greater Crohn’s disease clinical and research communities and benefit all patients.”

“The significant support from the Helmsley Charitable Trust will enable us to accelerate the development of much-needed anti-fibrotic therapies for patients with stricturing Crohn’s disease,” said Dr. Rieder, Cleveland Clinic.

“For patients with stricturing Crohn’s disease and their families, development of anti-fibrotic drugs could mean greatly reducing infections, pain, surgeries and hospitalizations that currently result from Crohn’s disease complications,” said Dr. Fletcher, Mayo Clinic.

“Robarts Clinical Trials, Inc. is proud to be an integral partner in a collaboration that brings together expertise in gastroenterology, radiology and clinical epidemiology to address a poorly studied clinical problem that affects many patients with Crohn’s disease,” said Dr. Feagan, Robarts Clinical Trials, Inc.

Through the development of patient reported outcome and imaging tools, the STAR consortium will help build a pathway to develop new, effective therapeutics for Crohn’s disease that will ultimately improve the well-being of patients.


Silan Akgul, Communications Associate


About the Helmsley Charitable Trust

The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning its active grantmaking in 2008, Helmsley has committed more than $2 billion for a wide range of charitable purposes. Helmsley’s Crohn’s Disease Program supports impactful ideas and mobilizes a global community committed to improving the lives of Crohn’s disease patients while pursuing a cure.  For more information, please visit helmsleytrust.org.

About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Among Cleveland Clinic’s 66,000 employees are more than 4,200 salaried physicians and researchers and 16,600 nurses, representing 140 medical specialties and subspecialties. Cleveland Clinic’s health system includes a 165-acre main campus near downtown Cleveland, 11 regional hospitals in northeast Ohio, more than 180 northern Ohio outpatient locations – including 18 full-service family health centers and three health and wellness centers – and locations in southeast Florida; Las Vegas, Nev.; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2018, there were 7.9 million total outpatient visits, 238,000 hospital admissions and observations, and 220,000 surgical cases throughout Cleveland Clinic’s health system. Patients came for treatment from every state and 185 countries. Visit us at clevelandclinic.org

About Mayo Clinic

Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, comprehensive care to everyone who needs healing. Learn more about Mayo Clinic. Visit the Mayo Clinic News Network.

About Robarts Clinical Trials Inc.

Robarts Clinical Trials Inc. (RCTI) is a global research organization providing clinical trial and central image management solutions (CIMS) to the pharmaceutical and biotechnology industries. Headquartered in London Ontario, RCTI employs more than 225 people across its operations in Canada, the United States, The Netherlands, Germany and the United Kingdom.  Its unique model combines the efforts of leading internationally recognized academic researchers with operational experts to offer integrated solutions to its pharmaceutical and biotechnology partners. Founded in 1986 at the Robarts Research Institute, the clinical trials division was initially led by Dr. Henry Barnett.  In 1997, Dr. Brian Feagan, Professor of Medicine, Epidemiology & Biostatistics at Western University assumed leadership and built on the foundation of academic excellence by focusing the organization towards Inflammatory Bowel Disease research. Over the past 22 years, RCTI has become recognized as the expert in clinical trial design, execution, outcome development and image management for drug development. In 2018, Robarts RCTI transitioned ownership from Western University to the Health Academic Research Trust. This new social enterprise structure prioritizes employees, R&D investment and strong fiscal management in support of its mission to transform human health. Robarts Clinical Trials Inc. provides services in over 55 countries worldwide, collaborates with leading academic research institutions across the globe and partners with many of the leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients.