Newswise – Phase 3 CELEBRATE The study testing a regenerative, stem cell-based therapy to treat patients with stress urinary incontinence continues to recruit more subjects after changing the study protocol to only include patients who have already undergone surgery.

Stress 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 tract. according to CELLEBRATE’s global principal investigator Melissa KaufmanMD, PhD, Chief of Reconstructive Urology and Pelvic Health at Vanderbilt University Medical Center (VUMC).

Half of the study participants will receive injections with cells and the other half will receive a placebo, although the placebo group will have the option to receive an injection with their cells after completing the blinded part of their study participation (12 months).

“This regenerative cell-based therapy is the latest advance for stress incontinence and the first to offer the potential of… “significant symptomatic benefit compared to simple disease and symptom relief,” said the principal investigator of the CELLEBRATE site Roger DmochowskiMD, Professor of Urology and Surgery and Deputy Chief Physician at VUMC.

“It is also the first regenerative option to undergo such rigorous clinical evaluation. It is likely to be a game-changer in providing diverse regeneration options to the next generation of women suffering from this common and extremely debilitating condition.”

The AMDC treatments are effective in treating age-related incontinence, injuries and previous surgeries that can affect urethral sphincter function, Kaufman said.

“The results so far suggest that this could be a permanent solution for years or decades and, more importantly, suitable for retreatment if necessary,” Kaufman said.

Current therapies for patients with stress urinary incontinence include pelvic floor physical therapy, Kegel exercises, vaginal inserts such as pessaries, urethral filler injections, and a variety of surgical sling or suspension procedures.

According to Kaufman, patients can see improvement in symptoms within a few months of the AMDC procedure. About 200 mg of the vastus lateralis in the thigh is taken through a biopsy and cultured and injected into the urethral sphincter, where the cells work on muscle regeneration. The injection took about two minutes, she said.

VUMC researchers are also studying AMDC applications for urinary continence, fecal incontinence, underactive bladder and tongue dysphagia following prostatectomy in patients with a history of oropharyngeal cancer.

“We sincerely hope that this technology will eventually be used in all of these different spectrums and touch so many lives,” Kaufman said.

For more information, see CELLEBRATE study site or contact [email protected].

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