The Program for Advanced Cell Therapy at the University of Wisconsin-Madison has received fast track designation from the FDA for an investigational cell therapy designed to treat xerostomia, or dry mouth, in patients with Sjögren’s disease.
The therapy is being tested in a clinical trial at the University of Wisconsin School of Medicine and Public Health, according to a Feb. 9 news release from the University. It uses interferon-gamma-activated autologous marrow stromal cells, processed at University Hospital in Madison, and injected into patients’ salivary glands to stimulate saliva production. The FDA issued an investigational new drug license for the therapy in 2023.
The trial will enroll six patients and is open to adults with Sjögren’s disease or graft-versus-host disease. A subsequent trial is expected to enroll 30 participants.
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