Treatment of Stress Urinary Incontinence in Women 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: NCT04446884
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 22
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Condition or Disease	Intervention/Treatment	Phase
Stress 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, method for the treatment of women stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen was developed.

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 stress urinary incontinence (SUI) in animals (female rats).

After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue, cultured and then transplanted back to directly under mucosa of urethra by three point injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the paraurethral area.

Injected volume was 3 ml per patient. For injection MSCs (6*10^6 cells) were mixed with collagen solution (3,5% w|w).

Follow up patients monitoring was mperformed at 2, 4, 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 Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mesenchymal stem cells Patients with Stress 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; Other: Standard treatment according to the Clinical protocols; Standard treatment according to the Clinical protocols
Active Comparator: control Patients with Stress 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

1. Number of cured patients [3 months]

   Number of patients cured

2. 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: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stress urinary incontinence

• absence of acute inflammatory manifestations in the genitourinary system

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	Hrodna City Clinical Hospital	Hrodna		Belarus	230009

Sponsors and Collaborators

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

Investigators

• Study Director: Igor D Volotovski, Prof, Head of the Lab of Institute of Biophysics and Cell Engineering
• Study Director: Alexander Nechiporenko, Dr, Associate Professor of Department of Surgical Diseases

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: NCT04446884
• Other Study ID Numbers: IBCE_MSC(UIW)
• First Posted: Jun 25, 2020
• Last Update Posted: Jun 25, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus: Stress Urinary Incontinence; Mesenchymal stem cells
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

No Results Posted as of Jun 25, 2020