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

NCT01850342 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-05-09

No results posted yet for this study

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

Interventions

PROCEDURE

Periurethral injection of fat micrograft enriched with ADRC

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.

Sponsors & Collaborators

  • Burnasyan Federal Medical Biophysical Center

    lead OTHER_GOV

Principal Investigators

  • Ilya I Eremin, MD, PhD · Burnasyan Federal Medical Biophysical Center

  • Pavel S Kyzlasov, MD · Burnasyan Federal Medical Biophysical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-03-31
Completion
2014-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01850342 on ClinicalTrials.gov