Effectiveness and Safety of Cell-Assisted Lipotransfer for the Treatment of Stress Urinary Incontinence

NCT01850342 | Unknown Phase 1

• 1 other identifier: RU-FMBC-01-01-13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Autologous washed and homogenized fat micrograft harvested from the patient's front abdominal wall enriched with adipose-derived regenerative cells (ADRC) derived by enzyme-treatment of a portion of the harvested fat. Fat tissue micrograft mixed with ADRC will be administered one-time endoscopically into submucosal layer of urethra under eye control. This is a single arm study with no control. All patients receive cell therapy.

Conditions

Stress Urinary Incontinence

Keywords

Male stress urinary incontinence; Cell-assisted lipotransfer; Adipose-derived regenerative cells; ADRC; Micrograft; Fat tissue; Stem cells

Outcome Measures

Primary Outcomes (1)

• Safety endpoints

  Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs)

  4 weeks after treatment

Secondary Outcomes (1)

• Efficacy endpoints

  2, 4, 8, 12, 16, 24 weeks after treatment

Study Arms (1)

Fat micrograft enhanced with ADRC

EXPERIMENTAL

Procedure: Periurethral injection of fat micrograft enriched with ADRC

Interventions

Periurethral injection of fat micrograft enriched with ADRC PROCEDURE

Subjects will undergo liposuction under local anesthesia. One part of lipoaspirate will be processed to isolate and concentrate ADRCs. Another part of lipoaspirate will be washed and homogenized to prepare fat tissue micrograft. After that fat tissue micrograft will be mixed with ADRC. Autologous fat micrograft enriched with ADRC will be injected at the bulbomembranous region of urethra circle-wise under endoscopic vision.

Fat micrograft enhanced with ADRC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient suffers from stress urinary incontinence due to insufficiency of the urethral sphincter at least for 2 years.
• Moderate and severe grade of urinary incontinence according to assessment made by investigator.
• Patient is familiar with Participant information sheet.
• Patient signed informed consent form.

You may not qualify if:

• Contraindications for local anesthesia.
• For the patients undergone surgical treatment of prostate cancer:
• Cancer relapse.
• prostate-specific antigen (PSA) level \>0.008 ng/mL.

Sponsors & Collaborators

• Burnasyan Federal Medical Biophysical Center: lead

Study Sites (1)

State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia; Center for Biomedical Technologies

Moscow, 123182, Russia

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ilya I Eremin, MD, PhD

  Burnasyan Federal Medical Biophysical Center

  PRINCIPAL INVESTIGATOR

• Pavel S Kyzlasov, MD

  Burnasyan Federal Medical Biophysical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 9, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

RU (1)