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Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture

NCT02869061 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-08-16

No results posted yet for this study

Summary

Autologous adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion from a portion of the fat harvested from the patient's front abdominal wall. Transurethral bladder neck resection followed by the injection of ADRCs suspension will be performed. This is a single arm study with no control. All patients receive cell therapy.

Conditions

  • Bladder Neck Obstruction
  • Bladder Outlet Obstruction
  • Benign Prostatic Hyperplasia
  • Urinary Bladder Neck Obstruction

Interventions

PROCEDURE

Liposuction

PROCEDURE

Transurethral bladder neck resection.

BIOLOGICAL

ADRC

Injection of ADRC suspension will be performed endoscopically into the bladder neck close to the site of resection.

OTHER

ADRC isolation

ADRC will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in up to 9.5 ml of normal saline.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

    lead OTHER_GOV

Principal Investigators

  • Denis V Butnaru, MD, PhD · I.M. Sechenov First Moscow State Medical University

  • Andrey A Pulin, MD, PhD · Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

  • Andrey Z Vinarov, MD, PhD, Prof · I.M. Sechenov First Moscow State Medical University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-12-31
Completion
2018-12-31

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 NCT02869061 on ClinicalTrials.gov