Following positive clinic trial results, Mayo Clinic lab is combining its stem cell research with a bioabsorbable material to create "a living drug" to help patients heal better.
Mayo Clinic and W. L. Gore & Associates Inc., the Newark, Del.-based firm best known for making Gore-Tex, are forming a joint venture called Avobis Bio to develop implantable cell therapies for difficult-to-treat conditions, such as perianal fistulas that afflict patients with Crohn's disease.
Work by Mayo Clinic's Immune, Progenitor and Cell Therapeutics (IMPACT) lab that uses a patient's stem cells to spur healing is at the heart of this project, explained Lab Director Dr. Allan Dietz. Dietz has been working on this treatment approach with Mayo Clinic colleagues Dr. William Faubion Jr. and Dr. Eric Dozois.
They created a treatment using mesenchymal stem cells taken from a sample of a patient's fat to encourage the body to heal painful fistulas, a tunnel that runs from inside the anus to somewhere in the skin around it. They reached out to Gore, which makes a bioabsorbable polymer "plug" for fistulas called Bio-A as way to deliver the specially prepared "highly potent" cells.
The idea is to help the body to heal itself.
"This really is new technology ... a living drug," said Dietz. "There isn't really anything out there like this."
Mayo Clinic tested stem cell-coated plug treatment in a phase I clinical with 20 patients and found 76 percent of patients "experienced healing at one year," according to Dietz.
Those results inspired the Mayo/Gore team to form Avobis Bio and move ahead with a larger phase II trial of the treatment. The next trial is slated to start in the second half of 2020.
"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," stated Paul Fischer, Corporate Development Leader at Gore and chairman of the Avobis Bio board, in the announcement of the Mayo Clinic joint venture.
Mayo's Faubion, a gastroenterologist who specializes in inflammatory bowel diseases, stated that, Perianal fistulas are truly life-altering for Crohn's patients, and treatment options have eluded gastroenterologists and surgeons for years."
The estimated $590 million global market for treatments of anal fistula is a growing one due to the rise in cases of Crohn's, tuberculosis, carcinoma and AIDS. It's expected to swell to an estimated value of $810 million by 2025.
The road map for the research is still being written, said Dietz, because the U.S. Food and Drug Administration is still working out how to approach a combined treatment such as this stem cell plus polymer scaffold.
He stressed that his joint venture brings Gore's strength as a material manufacturer with Mayo Clinic's clinic skills to develop "something new" with the potential to treat fistulas and possibly many more conditions.
Dietz's IMPACT Lab recently made news with a success in treating a completely paralyzed man's spine with stem cells, which resulted in a very limited ability to walk. Dietz says the lab has 16 clinic trials underway right now.
Mayo Clinic is expanding the lab, which has about 30 researchers, to occupy all of the downtown Hilton Building's second floor.