The Phase 3 CELLEBRATE trial to test a regenerative stem cell-based therapy in treating patients with stress urinary incontinence is continuing to recruit additional subjects after changing its study protocol to include only patients who have already tried surgery.
Stress urinary incontinence is the accidental loss of urine due to physical activity, such as laughing, coughing or sneezing.
The therapy, known as Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR, generic name: iltamiocel), involves a medical procedure in which a participant’s own muscle cells are collected, processed and then injected into the tissues of the urinary passage, according to CELLEBRATE global principal investigator Melissa Kaufman, MD, PhD, chief, Division of Reconstructive Urology and Pelvic Health at Vanderbilt University Medical Center.
Half of the participants receive injections with cells and the other half receive placebo, although the placebo group will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).
“This regenerative cell-based therapy is the newest frontier for stress incontinence and the first that offers the potential of a substantial symptomatic benefit, versus simply ameliorating the condition and the symptoms,” said CELLEBRATE site principal investigator Roger Dmochowski, MD, professor of Urology and Surgery and associate surgeon-in-chief at VUMC.
“It is also the first regenerative option that’s undergone such a rigorous clinical evaluation. Likely, it will lead the way in providing a variety of regenerative options to the next generation of women who experience this highly prevalent and significantly bothersome condition.”
The AMDC treatments have been effective in treating incontinence from aging, injury and prior surgeries that can degrade the urethral sphincter muscle function, Kaufman said.
“The results to date indicate that this may be a durable solution over years or decades and, importantly, amenable to retreatment if needed,” Kaufman said.
Current therapies for patients with stress urinary incontinence include pelvic floor physical therapy, Kegel exercises, vaginal inserts such as pessaries, injections of urethral bulking agents, and a variety of surgical sling or suspension procedures.
Kaufman says patients may see symptom improvement within a few months of the AMDC procedure, which harvests and cultures approximately 200 mg of the vastus lateralis in the thigh through a biopsy and injects it into the urethral sphincter muscle, where the cells work to regenerate muscle. The injection takes about two minutes, she said.
VUMC researchers are also exploring AMDC applications for post-prostatectomy urinary continence, fecal incontinence, underactive bladder, and tongue dysphagia in patients with a history of oropharyngeal cancer.
“This technology will eventually, we sincerely hope, be employed across all these different spectrums and touch so many lives,” Kaufman said.
For more information, go to the CELLEBRATE study site or contact brianne.duncan@vumc.org.