NCT01889888

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 1, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

June 25, 2013

Last Update Submit

June 26, 2013

Conditions

Urethral Strictures in Males

Keywords

Male urethral strictureADRCAdipose-derived regenerative cellsFat tissueStem cells

Outcome Measures

Primary Outcomes (2)

  • Safety endpoint-1

    Types, probability and severity of treatment emergent serious adverse events (SAEs)

    4 weeks after treatment

  • Safety endpoint-2

    Types, probability and severity of treatment emergent serious adverse reactions (SARs)

    4 weeks after treatment

Secondary Outcomes (3)

  • Efficacy endpoint-1

    10 days, 4, 12, 24, 48 weeks after treatment

  • Efficacy endpoint-2

    10 days, 4, 12, 24, 48 weeks after treatment

  • Efficacy endpoint-3

    10 days, 4, 12, 24, 48 weeks after treatment

Study Arms (1)

ADRC injection

EXPERIMENTAL
Other: Submucosal injection of ADRC

Interventions

Submucosal injection of ADRCOTHER

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.

ADRC injection

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications for local anesthesia
  • For the patients undergone surgical treatment of prostate cancer:
  • Cancer relapse
  • prostate-specific antigen (PSA) level \>0.008 ng/mL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 123182, Russia

Location

Study Officials

  • Ilya I Eremin, MD, PhD

    Burnasyan Federal Medical Biophysical Center

    PRINCIPAL INVESTIGATOR

  • Pavel S Kyzlasov, MD

    Burnasyan Federal Medical Biophysical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 25, 2013

First Posted

July 1, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2014

Study Completion

May 1, 2015

Last Updated

July 1, 2013

Record last verified: 2013-06

Locations

RU(1)