NCT04426643

Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells

Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel and Injected Submucousely

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Other Government
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Treatment of patients with urinary incontinence after prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Detailed description

During the implementation of the project, it is planned to develop a method for the treatment of men urinary incontinence caused by prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the effectiveness of MSCs is due to the following: * the ability of MSCs to stimulate tissue regeneration * positive results of preclinical studies of the method of treatment of urinary incontinence in animals. In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured and then transplanted back to the periurethral area by five point injection in rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in submucosal space MSCs (20\*10\^6 cells) will be mixed with collagen solution (3,5% w\|w). Follow up patients monitoring will occur at 1，3，6 and 12 months after injection.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	Autologous adipose-derived mesenchymal stem cells	Autologous adipose-derived mesenchymal stem cells mixed with collagen solution injected in submucosal space
OTHER	Standard treatment according to the Clinical protocols	Standard treatment according to the Clinical protocols

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-02-20
• Completion: 2021-03-31
• First posted: 2020-06-11
• Last updated: 2021-05-25

Locations

1 site across 1 country: Belarus