The Phase 3 CELLEBRATE trial to test a regenerative stem cell-based therapy in treating patients with stress urinary incontinence is continuing to recruit addit
The Phase 3 CELLEBRATE trial to test a regenerative stem cell-based therapy in treating patients with stress urinary incontinence is continuing to recruit addit
FDA Grants RMAT designation for Cook MyoSite’s Investigational Autologous Muscle Derived Cells for Urinary Sphincter Repair PITTSBURGH (Business Wire) Cook MyoSite, a biotechnology firm based in Pittsburgh, Pennsylvania, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Cook MyoSite’s investigational product, Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR), for treatment of women with persistent or recurrent stress urinary incontinence (SUI) following surgical treatment.
Implicit in the RMAT designation is an acknowledgement that SUI meets the FDA s definition of a serious condition in cases where women continue to experience incontinence episodes that have a substantial impact on day-to-day functioning despite having undergone surgical treatment. This acknowledgment represents a major step forward for these patients, many of whom suffer significantly from thi