Innovation study

• Research type

  Research Study

• Full title

  A multicenter, randomized, doubleblinded, parallel-group, placebocontrolled study to assess the efficacy and safety of skeletal muscle-derived cell implantation in female patients with stress urinary incontinence

• IRAS ID

  101854

• Contact name

  Neil Harris

• Sponsor organisation

  Innovacell Biotechnologie AG

• Eudract number

  2010-021871-10

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Urinary incontinence is any involuntary leakage of urine. It is a common, distressing problem and can be a devastating social disability (reduced self-esteem, social isolation, diminished quality of life). Stress urinary incontinence (SUI) is the loss of small amounts of urine associated with coughing, laughing, sneezing, exercising or other movements. SUI is characterised by impaired function of the urethral sphincter complex. The urethral sphincter is a muscular coat that is responsible for the urethral closure mechanism holding the urine. Currently available alternative treatments for SUI have little impact on the causes of this disorder; only surgery is generally regarded as the method with best chances of cure or significant improvement. The treatment under investigation in this study aims at treating the cause of SUI, thus ensuring a long-term treatment effect. In this study, a ??tissue engineering product?? will be applied. Tissue engineering means the use of cells to repair or replace portions or whole tissues of the body. In the context of this study, it means to provide a functional regeneration of your weakened sphincter by multiplying and reintroducing your own cells. Therefore, a biopsy will be taken from a muscle of your upper arm or axilla. The isolated tissue cells will be cultivated in a laboratory. The resulting multiplied cells (SMDCs) will be injected in the weakened muscle, and thus, your own cells will be used for the therapy. In the course of this study, the SMDCs will be compared against placebo. A placebo is a substance that does not contain any active ingredient but is optically indistinguishable from the active treatment. The comparison to placebo enables us to assess the efficacy and the side effects of the SMDC therapy. The aim of this study is to show efficacy and safety of SMDCs in female patients and to show superiority of SMDCs over placebo.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  12/LO/1383

• Date of REC Opinion

  18 Dec 2012

• REC opinion

  Further Information Favourable Opinion