The University Hospital of Navarra is to carry out clinical trials for urinary incontinence using the intraurethral injection of myoblasts (adult stem cells obtained by means of a biopsy of the patient).
The trials will be undertaken with 15 women with urinary incontinence. The project is to recruit the sufferers over a six-month period and to carry out the project jointly between the Cellular Therapy Area and the Department of Urology at the University Hospital of Navarra.
Amongst adult women, incontinence is largely due to the loss of muscular mass of the sphincter, recoverable by injecting this sphincter zone with the patient’s own muscle cells (myoblasts) with the objective of regenerating this muscle, enhancing its contractility and reducing incontinence.
The knowledge of this technique worldwide is confined to less than 200 patients: half a dozen in Canada and about 180 in Austria. The initial idea is the same, although there are differences in how the cells are obtained and in their processing.
The treatment of cystoceles (prolapses of the bladder) is currently undertaken using meshes that act to reinforce the original tissues. These are usually synthetic or of natural (biological) origin, but other, hybrid materials, are being worked with.
Thus, with this collaboration between the Department of Urology and the Cellular Therapy Area in adult stem cell therapy for the treatment of urinary incontinence and prolapses of the pelvic organs, there is another line of research: the use of biological meshes as a support or as “scaffolding” onto which cells are infiltrated so that the myofibroblasts might grow. It is intuitive to believe that the mesh becomes covered with the fibromuscular cells themselves, and that they penetrate the mesh. It is this that is really the reinforcement; the mesh is but a supportive scaffolding rather than an end in itself.
Cooperating in carrying out this project is the BARD company, which manufactures and markets biological meshes. A number of in vitro studies and experiments with animals will be undertaken in order to favour cell growth on the biological meshes and the effect of these with a number of agents. Then they will be implanted in model experimental animals to examine their capacity to integrate into the tissue and carry out the function of support.