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

NCT ID: NCT01889888

Last Updated: 2013-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-05-31

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.

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.

Conditions

Urethral Strictures in Males

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADRC injection

Group Type: EXPERIMENTAL

Submucosal injection of ADRC

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Burnasyan Federal Medical Biophysical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Pavel Kyzlasov

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilya I Eremin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Burnasyan Federal Medical Biophysical Center

Pavel S Kyzlasov, MD

Role: PRINCIPAL_INVESTIGATOR

Burnasyan Federal Medical Biophysical Center

Locations

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

Moscow, , Russia

Countries

Russia

Other Identifiers

RU-FMBC-01-02-13

Identifier Type: -

Identifier Source: org_study_id