Trial | NCT04426643  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
Treatment of patients with urinary incontinence after prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel
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.
Study Started
Aug 01
2020
Primary Completion
Feb 20
2021
Study Completion
Mar 31
2021
Last Update
May 25
2021

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

mesenchymal stem cells Experimental

Patients with Urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells

control Active Comparator

Patients with Urinary incontinence receiving standard treatment

Criteria 

Inclusion Criteria:

Urinary incontinence
absence of acute inflammatory manifestations in the genitourinary system
period after prostatectomy is at least 12 months

Exclusion Criteria:

urethral or bladder malformations
acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
mental disorders
No Results Posted