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

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ClinicalTrials.gov Identifier: NCT01889888
Recruitment Status : Unknown
Verified June 2013 by Pavel Kyzlasov, Burnasyan Federal Medical Biophysical Center.
Recruitment status was:  Enrolling by invitation
First Posted : July 1, 2013
Last Update Posted : July 1, 2013
Sponsor:
Information provided by (Responsible Party):
Pavel Kyzlasov, Burnasyan Federal Medical Biophysical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Urethral Strictures in Males Other: Submucosal injection of ADRC Phase 1 Phase 2

Detailed Description:

Fat tissue obtainment. Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.

ADRC isolation. Aspirated fat tissue placed into sterile vessel which inserted into Celution 800/CRS System (Cytori Therapeutics Inc) - closed system for automated and standardized extraction and concentration of ADRC. Celution 800/CRS System drains excess of fluid from fat tissue and estimate it's volume After that lipoaspirate washed extensively with equal volumes of Ringer's solution to remove blood. At the end of this process System indicates required volume of enzyme reagent (Celase®) which should be added immediately by operator. After enzyme treatment Celution 800/CRS System automatically transfers isolated ADRC into washing compartment where ADRC washed and concentrated in 5 mL suspension. Tissue processing time - approximately 60 minutes. ADRC suspension match all requirements listed in technical documentation for Celution 800/CRS System. Obtained ADRC divided into 2 portions. First portion (0.2-0.5 mL) used for counting, viability and sterility assessment. Second portion placed into sterile syringe for injection.

Urethral stricture dilation. Under direct vision HiWire® hydrophilic nitinol wire positioned through the urethra and exchanged for a stiff-bodied wire. After that S-Curve urethral dilators (Cook Medical Inc.) passed over the wire guide progressing from the smallest to the largest 24(Fr) appropriate size while maintaining the wire guide's position.

Periurethral injection of ADRC. After dilation needle for injection introduced into urethra using endoscope. Urethra punctured several times circle-wise at the region of stricture at depth of 5 mm under endoscopic vision and 0.3-0.5 mL of ADRC suspension injected submucosally each time. Total volume of solution injected depends on stricture length and technical possibilities. Minimal injected volume - 3 mL, maximal - 4.5 ml. After fat micrograft injected, urethral balloon catheter placed and removed the following day.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Endoscopically-Assisted Submucosal Administration of Autologous Adipose-Derived Regenerative Cells for the Treatment of Urethral Strictures
Study Start Date : June 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: ADRC injection 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.




Primary Outcome Measures :
  1. Safety endpoint-1 [ Time Frame: 4 weeks after treatment ]
    Types, probability and severity of treatment emergent serious adverse events (SAEs)

  2. Safety endpoint-2 [ Time Frame: 4 weeks after treatment ]
    Types, probability and severity of treatment emergent serious adverse reactions (SARs)


Secondary Outcome Measures :
  1. Efficacy endpoint-1 [ Time Frame: 10 days, 4, 12, 24, 48 weeks after treatment ]
    Retrograde urethrogram

  2. Efficacy endpoint-2 [ Time Frame: 10 days, 4, 12, 24, 48 weeks after treatment ]
    Urodynamic studies: postvoid residual (PVR) volume measurement, uroflowmetry.

  3. Efficacy endpoint-3 [ Time Frame: 10 days, 4, 12, 24, 48 weeks after treatment ]
    Quality of life measured by the International Prostatic Symptom Score (IPSS) and the Short Form (36) Health Survey (SF-36).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient suffers from urethral strictures at least for 1 year
  • Moderate and severe grade of obstructive voiding symptoms according to assessment made by investigator
  • Patient is familiar with Participant information sheet.
  • Patient signed informed consent form

Exclusion Criteria:

-Contraindications for local anesthesia

For the patients undergone surgical treatment of prostate cancer:

  • Cancer relapse
  • prostate-specific antigen (PSA) level >0.008 ng/mL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889888


Locations
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Russian Federation
State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia; Center for Biomedical Technologies
Moscow, Russian Federation, 123182
Sponsors and Collaborators
Burnasyan Federal Medical Biophysical Center
Investigators
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Principal Investigator: Ilya I Eremin, MD, PhD Burnasyan Federal Medical Biophysical Center
Principal Investigator: Pavel S Kyzlasov, MD Burnasyan Federal Medical Biophysical Center

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Responsible Party: Pavel Kyzlasov, MD, Burnasyan Federal Medical Biophysical Center
ClinicalTrials.gov Identifier: NCT01889888     History of Changes
Other Study ID Numbers: RU-FMBC-01-02-13
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: June 2013

Keywords provided by Pavel Kyzlasov, Burnasyan Federal Medical Biophysical Center:
Male urethral stricture
ADRC
Adipose-derived regenerative cells
Fat tissue
Stem cells

Additional relevant MeSH terms:
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Constriction, Pathologic
Urethral Stricture
Pathological Conditions, Anatomical
Urethral Obstruction
Urethral Diseases
Urologic Diseases