NEWARK — W.L. Gore & Associates Inc. and Mayo Clinic have formed a joint venture that will seek to create a product that utilizes stem cells to treat a painful condition connected to Crohn's disease. If successful, it could lead to other implantable cell therapies to treat other debilitating conditions with no cure.
The for-profit venture, Avobis Bio, will combine the Minnesota-based Mayo Clinic's clinical and cell expertise and Newark-based Gore’s expertise in material science to address some of the most challenging medical issues, officials said in announcing the effort. Specifically, it will explore the use of mesenchymal stem cells combined with enabling bioabsorbable scaffolds that enhance the effectiveness of the cells in stimulating the body to heal.
According to the Mayor Clinic, stem cells are the body's raw materials — cells from which all other cells with specialized functions are generated. Under the right conditions in the body or a laboratory, stem cells divide to form more cells, which can also be specified for other functions. Researchers hope to harness the potential of stem cells and make an implantable patch that would aid in a patient’s treatment.
Mayo Clinic brings a depth of clinical experience and infrastructure to the team, as well as scientific research and development related to cell therapy. This complements Gore’s experience applying material science expertise in developing and commercializing products in the biopharmaceutical and medical device industries.
The joint venture initially will focus on developing a regenerative approach to treat perianal fistulas, a debilitating condition that afflicts patients with Crohn's disease. Perianal fistulas are painful tunneling wounds connecting the rectum or anus to the skin. Few healing options exist, and patients endure multiple surgeries and ongoing risk of life-threatening complications.
"Perianal fistulas are truly life-altering for Crohn's patients, and treatment options have eluded gastroenterologists and surgeons for years," said Dr. William Faubion Jr., a Mayo Clinic gastroenterologist who specializes in inflammatory bowel diseases, in a statement. "We are excited for the opportunity to work with a partner with such distinct expertise and with a shared mission to advance innovative and patient-centric solutions."
Working closely with the team of experts at Gore, Faubion and Mayo Clinic colleagues Dr. Eric Dozois and Allan Dietz, Ph.D., have developed an innovative investigational treatment for perianal fistulas that has shown promising results in a recent clinical trial. Dozois is a colon and rectal surgeon while Dietz directs the Immune, Progenitor and Cell Therapeutics (IMPACT) Laboratory.
The treatment involves harvesting and processing a patient's own mesenchymal stem cells, which then are populated on Gore's bioabsorbable polymer scaffold and surgically implanted in the fistula. In a phase I clinical trial, 76% of patients experienced healing at one year, which if validated in a larger trial would dramatically exceed outcomes achieved with existing conventional treatment, officials reported.
"We are encouraged by the results of the recent clinical trial and look forward to improving clinical outcomes for patients with perianal fistulas," said Paul Fischer, Gore associate and chairman of the Avobis Bio board of managers, in a statement. "We believe mesenchymal stem cells, combined with enabling scaffolds, have a great deal of potential to successfully treat a range of very challenging clinical conditions beyond this initial therapy."
By Jacob Owens