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

Sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus (Other)

Overall Status

Completed

CT.gov ID

NCT04426643

Collaborator

The state institution N. N. Alexandrov National Cancer Centre of Belarus (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Biological: Autologous adipose-derived mesenchymal stem cells Other: Standard treatment according to the Clinical protocols	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Feb 20, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mesenchymal stem cells Patients with Urinary incontinence receiving standard treatment plus adipose-derived mesenchymal stem cells	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
Active Comparator: control Patients with Urinary incontinence receiving standard treatment	Other: Standard treatment according to the Clinical protocols Standard treatment according to the Clinical protocols

Arm

Intervention/Treatment

Experimental: mesenchymal stem cells

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

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

Active Comparator: control

Patients with Urinary incontinence receiving standard treatment

Other: Standard treatment according to the Clinical protocols

Standard treatment according to the Clinical protocols

Outcome Measures

Primary Outcome Measures

Number of cured patients [3 months]
Number of patients cured
Number of patients with treatment-related adverse events [4 weeks]
MSC application related adverse events assessed by blood count, liver and function tests

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk		Belarus	220072

Sponsors and Collaborators

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
The state institution N. N. Alexandrov National Cancer Centre of Belarus

Investigators

Study Director: Igor D Volotovski, Dr, Head of the Lab of Institute of Biophysics and Cell Engineering
Study Director: Sergey A Krasny, Dr, Deputy Director for Research of the National Cancer Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT04426643

Other Study ID Numbers:

IBCE_MSC(UIM)

First Posted:

Jun 11, 2020

Last Update Posted:

May 25, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Urinary incontinence

Prostatectomy

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Study Results

No Results Posted as of May 25, 2021