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Effectiveness and Safety of Autologous Adipose-Derived Regenerative Cells for the Treatment of Urethral Strictures

NCT01889888 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-07-01

No results posted yet for this study

Summary

Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc)from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time endoscopically into submucosal layer of urethra under eye control into the stricture site after mechanical dilation. This is a single arm study with no control. All patients receive cell therapy.

Conditions

  • Urethral Strictures in Males

Interventions

OTHER

Submucosal injection of ADRC

Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate ADRCs. Patients will undergo mechanical dilation followed by submucosal periurethral ADRC injections circle-wise into stricture site 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
2013-06-30
Primary Completion
2014-10-31
Completion
2015-05-31

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 NCT01889888 on ClinicalTrials.gov