Cell therapy for incontinence maintained its effect at one year in 12 of 13 women in a phase two trial

Cell therapy for incontinence maintained its effect at one year in 12 of 13 women in a phase two trial

On October 7, Swiss biotechnology company MUVON published interim phase two trial results for its treatment for stress urinary incontinence, which causes urine leakage during coughing, laughing, or physical exertion. The trial registry lists 30 participants; the company's one-year report covers 13 of them.

The external urethral sphincter, a muscle at the bladder outlet, holds urine in. In stress urinary incontinence, this muscle weakens, allowing urine to leak during coughing, laughing, or physical exertion. MUVON takes a small sample of the patient's calf muscle, grows her own muscle progenitor cells from it, and injects them through the urethra directly into the sphincter under ultrasound guidance. The procedure aims to restore the muscle's ability to contract.

In the phase two trial, 30 women were randomly assigned to receive one of two cell doses. The lower dose had already been tested in phase one, while the higher dose was assessed for efficacy in this trial. At six months, the company reported reductions in the frequency of incontinence episodes and the volume of urine leakage from baseline. The release gives p<0,0001 for both measures, indicating that differences of this size from baseline would be difficult to explain by random variation.

The one-year follow-up was intended to establish whether the effect persisted. So far, 13 participants have reached this point; 12 of them had already responded to treatment at six months. All twelve maintained the response at one year, with episode frequency reduced by 79% and leakage volume by 85% from baseline. The company also reports no serious adverse events related to the treatment or procedure and preserved tissue integrity in all participants assessed at one year.