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

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Completed; Phase 2; Phase 1

Conditions: Urinary Incontinence

Treatments: Biological: Autologous adipose-derived mesenchymal stem cells; Other: Standard treatment according to the Clinical protocols

Study type: Interventional

Funder types: Other

Identifiers

NCT04426643

IBCE_MSC(UIM)

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

mesenchymal stem cells

Experimental group

Description:

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

Treatment:

Biological: Autologous adipose-derived mesenchymal stem cells

Other: Standard treatment according to the Clinical protocols

control

Active Comparator group

Description:

Patients with Urinary incontinence receiving standard treatment

Treatment:

Other: Standard treatment according to the Clinical protocols