Cell therapy for treating stress urinary incontinence.

ICES13

About 30% of adult women and 10% of adult men suffer from urinary incontinence. The most common type of bladder weakness is stress urinary incontinence whereby an increase in pressure in the abdomen, such as when coughing, sneezing, climbing stairs or other physical exertion, can lead to involuntary urine loss. This is often caused by the responsible sphincter becoming weakened or injured. Current treatment methods include conservative therapies (e.g. pelvic floor training, biofeedback, pelvic training), various pharmaceuticals, surgical interventions and implantable medical devices.

Some of these existing therapies are inadequate or have undesirable side effects. Therefore, there is a great medical need for long-term effective and safe therapies for treating urinary incontinence.

In contrast to previous therapeutic approaches, the cell therapyICES13, currently in clinical development, is based on the principle of regenerating the sphincter by using autologous muscle cells. This is to treat the cause of the disease, strengthen the weakened muscle, and restore its original function. ICES13 is made from autologous skeletal muscle cells that have been isolated from a muscle biopsy and reproduced in a laboratory. The goal is to treat the cause of the stress urinary incontinence by subsequently injecting ICES13 into the sphincter muscle of the affected person.

After phase I and II clinical trials, a phase IIb study was successfully carried out in 2010/2011. In mid-2011, Innovacell started a multicenter and multinational phase III study, which has provided new, ground-breaking insights. In parallel, a pharmacodynamic study was carried out in Slovenia until 2015. To date, study results from 32 clinics in 7 European countries are available.

Innovacell is the world’s first cell therapy company to have reached this advanced development stage for treating stress urinary incontinence.

Development Status ICES13

EU

Preclinical

Clinical

Approval

Status

Study design for Phase III
Japan

Preclinical

Clinical

Approval

Status

N/A
USA

Preclinical

Clinical

Approval

Status

Scientific Advice conducted