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Allegheny Health Network Launches First U.S. Clinical Trial Testing Extracellular Matrix as Replacement for Pre-Cancerous Tissue

Tuesday, April 28, 2015

Investigational Trial Could Bring Effective New Option for People at High Risk of Esophageal Cancer

PITTSBURGH - An Allegheny Health Network (AHN) team led by Blair A. Jobe, MD, FACS, has launched the first U.S. clinical trial to investigate whether replacing esophageal tissue with extracellular matrix (ECM) can help patients who are at high risk of developing a lethal form of esophageal cancer.  
ECM is a complex mixture of naturally-occurring polymers that provides a framework for cell attachment and migration and signals that guide cell behavior. ECM, manufactured from pig urinary bladder, holds great promise for facilitating repair of human tissues.
“People with high-grade esophageal dysplasia, or precancerous cell changes, are at very high risk of developing esophageal cancer, a disease that is too often deadly,” said Dr. Jobe, Director of the Esophageal and Lung Institute at Allegheny Health Network. “These patients may even already have early-stage esophageal cancer.”
“The outcome of this clinical trial could give us an effective new option for treating these patients and a powerful tool for the prevention of esophageal cancer while preserving the esophagus,” Dr. Jobe said “The incidence of esophageal cancer is rising worldwide, and the disease is typically detected at advanced stages, when effective treatment options are few.”
The FDA recently granted permission for the Esophageal and Lung Institute clinical research team to enroll patients into this investigational study. The goal of the study is to preserve the esophagus, remove the dysplasia, and prevent side effects such as scar tissue formation that can negatively impact the patient’s quality of life.
“This long-awaited clinical trial is the culmination of years of work by Dr. Jobe and his team, and is some of the most exciting work now being done in the field of regenerative medicine,” said Alan Russell, PhD., Chief Innovation Officer and Executive Vice President, AHN, and founding president of the Tissue Engineering and Regenerative Medicine International Society.
Dr. Jobe and his team will use a technique known as transoral endoscopic circumferential resection (TECR), which is performed through the mouth, with no external incisions. The study will use two devices, an esophageal stent and ECM, that are approved by the FDA, though not for this specific purpose. The procedure involves removing a layer of the diseased esophageal tissue, and replacing it with an ECM, trade-named MatriStem, manufactured by ACell Inc. The team will study whether the ECM will facilitate healing of the tissue resection by the body and reduce the risk of stricture formation, which can make swallowing difficult.
“This clinical trial, the first of its kind in the U.S., reinforces the AHN Esophageal and Lung Institute’s position as both a regional and national leader in innovative, personalized treatment for esophageal and lung disease,” said Rodney Landreneau, MD, Co-Director of AHN Esophageal and Lung Institute, Division Director of General Thoracic Surgery and System Director of Thoracic Oncology.
Current available treatments for high-grade dysplasia, including burning or cutting away the diseased tissue, may not be effective for patients with extensive or recurrent disease. Removing the esophagus, while still considered the best treatment for increasing life expectancy, is an aggressive option that can present quality-of-life issues for some patients.
The AHN study will enroll 10 patients between 18 and 80 years of age with biopsy-proven circumferential high-grade dysplasia. They must complete a series of tests before they undergo the procedure at AHN’s West Penn Hospital. Follow-up endoscopies will be performed at 1, 3, 6, 9 and 12 months post-procedure to evaluate its effectiveness.
For more information on enrollment, contact Emily Lloyd at 412.578.1343.
About the Allegheny Health Network:
Allegheny Health Network, part of Highmark Health, is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network is comprised of eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital;  a research institute; Health + Wellness Pavilions; an employed physician organization, home and community based health services and a group purchasing organization. The Network employs approximately 17,500 people and has more than 2,100 physicians on its medical staff.   The Network also serves as a clinical campus for Temple University School of Medicine, Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.