Bladder Neck ObstructionPhase 1/2NCT02869061

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

A Phase 1/2 study testing Liposuction, Transurethral bladder neck resection. and ADRC in people with Bladder Neck Obstruction and Bladder Outlet Obstruction, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 2 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 70 years, men only
Conditions the study is for: Bladder Neck Obstruction, Bladder Outlet Obstruction, Benign Prostatic Hyperplasia
What is being tested?: Liposuction, Transurethral bladder neck resection. and ADRC
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesRussia
Study dates: Jan 2016to Dec 2018
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Bladder neck contracture after transurethral prostate resection.
Obstructive pattern of urine flow rate with maximum flow rate below 15 mL/s
Patient is familiar with Participant information sheet
Patient signed informed consent form
Non-inclusion Criteria:
Contraindications for spinal, epidural or inhalation anesthesia

Show all 18Show fewer

Urethral strictures
Genitourinary inflammatory diseases
Prostate-specific antigen (PSA) level above 4 ng/mL
Contraindications for local anesthesia or history of allergy for local anesthetics
Systemic glucocorticoid and/or immunosuppressant therapy
Any condition that might limit compliance (dementia, mental disorders, narcotic drug or alcohol abuse etc.)
Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy
Clinically significant abnormalities in results of laboratory tests
Patient received anticoagulants at least 12 hours prior the liposuction
Medical history of heterotopic ossifications
Patients prescribed for glycoprotein inhibitors treatment

Who cannot join

Patient's refusal from the further participation in trial
Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula)
Confirmed syphilis, HIV, hepatitis B or C infections

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

I.M. Sechenov First Moscow State Medical University
Moscow, 119991
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Moscow, 121359

Other trials in Russia

About this study

Official title: Effectiveness and Safety of Local Endoscopically-assisted Administration of Autologous Adipose-derived Regenerative Cells for Reduction of Risk of Postoperative Bladder Neck Contracture in Male Patients

Read the 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:

Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 9.5 ml of normal saline.Obtained ADRC divided into 2 portions. First portion (0.5 mL) used for counting, viability and sterility assessment. The second portion (9 ml) placed into sterile syringe for injection.

Surgery:

Transurethral endoscopic loop resection of bladder neck will be performed.

Autologous ADRC administration:

Injection of ADRC suspension will be performed immediately after bladder neck resection. 9 to 18 injections (0.5 to 1.0 mL each) will be injected with endoscopic needle into the bladder neck close to the site of resection. All injections will be performed during single procedure.

Conditions: Bladder Neck Obstruction, Bladder Outlet Obstruction, Benign Prostatic Hyperplasia, Urinary Bladder Neck Obstruction
Being tested: Liposuction, Transurethral bladder neck resection., ADRC, ADRC isolation
Keywords: Bladder neck obstruction, Bladder outlet obstruction, Benign prostatic hyperplasia, Urinary bladder neck obstruction, Bladder neck contracture, Bladder neck stricture, Bladder neck stenosis, Transurethral resection of the prostate, Prostatectomy, Stromal vascular fraction (SVF), Adipose-derived regenerative cells (ADRC), Adipose tissue, Stem cells
Medical subject headings: Urinary Bladder Neck Obstruction, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LiposuctionProcedure or surgery
Transurethral bladder neck resection.Procedure or surgery
ADRCBiological
Also called Adipose-derived regenerative cells
Injection of ADRC suspension will be performed endoscopically into the bladder neck close to the site of resection.
ADRC isolationOther
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.

Study groups in NCT02869061
Study group	Role	What they receive
ADRC injection	Experimental	Subjects will be undergone liposuction under local anesthesia. Adipose-derived regenerative cells (ADRC) will be isolated from lipoaspirate by enzymatic digestion. Transurethral bladder neck resection followed by the injection of ADRC suspension will be performed. This is a single arm study with no control. All patients receive cell therapy. Receives: Procedure: Liposuction; Procedure: Transurethral bladder neck resection.; Biological: ADRC; Other: ADRC isolation

What is being measured

The primary outcome is the main question the study is designed to answer.

Serious adverse events
Frequency, type and severity of serious adverse events (SAE)
Measured: 4 weeks after injection of ADRC suspension
Serious adverse reactions
Frequency, type and severity of serious adverse reactions (SAR)
Measured: Time Frame: 4 weeks after injection of ADRC suspension

Secondary outcomes (8)

Changes of the volume of residual urine
Influence of the procedure on the volume of residual urine assessed by ultrasonography
Measured: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 1
Influence of the intervention on urinary flow rate: maximum flow rate
Measured: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 2
Influence of the intervention on urinary flow rate: average flow rate
Measured: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 3
Influence of the intervention on urinary flow rate: total volume voided
Measured: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 4
Influence of the intervention on urinary flow rate: maximum flow time
Measured: Follow up to completion (48 weeks after intervention)
Quality of life monitoring - 1
Quality of life estimated by validated questionnaire: the Short Form (SF-36).
Measured: Follow up to completion (48 weeks after intervention)
Quality of life monitoring - 2
Quality of life estimated by validated questionnaire: International Prostatic Symptom Score (IPSS).
Measured: Follow up to completion (48 weeks after intervention)
Bladder neck restenosis control
Revision of bladder neck structure by retrograde urethrography
Measured: Follow up to completion (48 weeks after intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Dec 2018

First posted16 Aug 2016 (estimated)
Study startJan 2016
Primary completionDec 2017 (estimated)
Study completionDec 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bladder Neck ObstructionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02869061
Sponsor's protocol ID: RU-CCH-01-02-15
Status last verified: Aug 2016
First submitted: 8 Aug 2016
Last updated: 16 Aug 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia
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Recruiting
A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptom

All Bladder Neck Obstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety of Local Endoscopically-assisted Administration of Autologous Adipose-derived Regenerative Cells for Reduction of Risk of Postoperative Bladder Neck Contracture in Male Patients
ClinicalTrials.gov ID: NCT02869061
Acronym / sponsor ID: RU-CCH-01-02-15
Conditions: Bladder Neck Obstruction, Bladder Outlet Obstruction, Benign Prostatic Hyperplasia, Urinary Bladder Neck Obstruction
Keywords: Bladder neck obstruction, Bladder outlet obstruction, Benign prostatic hyperplasia, Urinary bladder neck obstruction, Bladder neck contracture, Bladder neck stricture, Bladder neck stenosis, Transurethral resection of the prostate
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 12 participants (estimated)
Lead sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian FederationOther government
Collaborators: I.M. Sechenov First Moscow State Medical University
Study start: Jan 2016
Primary completion: Dec 2017 (estimated)
Study completion: Dec 2018 (estimated)
First posted: 16 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Fat tissue obtainment:

ADRC isolation:

Surgery:

Transurethral endoscopic loop resection of bladder neck will be performed.

Autologous ADRC administration:

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ADRC injection	Experimental	Procedure: Liposuction, Procedure: Transurethral bladder neck resection., Biological: ADRC, Other: ADRC isolationSubjects will be undergone liposuction under local anesthesia. Adipose-derived regenerative cells (ADRC) will be isolated from lipoaspirate by enzymatic digestion. Transurethral bladder neck resection followed by the injection of ADRC suspension will be performed. This is a single arm study with no control. All patients receive cell therapy.

Who may qualify

Ages: 40 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Bladder neck contracture after transurethral prostate resection.
Obstructive pattern of urine flow rate with maximum flow rate below 15 mL/s
Patient is familiar with Participant information sheet
Patient signed informed consent form
Contraindications for spinal, epidural or inhalation anesthesia

Key exclusion criteria (3 listed)

Patient's refusal from the further participation in trial
Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula)
Confirmed syphilis, HIV, hepatitis B or C infections

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Liposuction	Procedure or surgery	ADRC injection
Transurethral bladder neck resection.	Procedure or surgery	ADRC injection
ADRCAlso: Adipose-derived regenerative cellsInjection of ADRC suspension will be performed endoscopically into the bladder neck close to the site of resection.	Biological	ADRC injection
ADRC isolationADRC 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.	Other	ADRC injection

Primary outcome

Serious adverse events
Time frame: 4 weeks after injection of ADRC suspension
Frequency, type and severity of serious adverse events (SAE)
Serious adverse reactions
Time frame: Time Frame: 4 weeks after injection of ADRC suspension
Frequency, type and severity of serious adverse reactions (SAR)

8 secondary outcomes

Changes of the volume of residual urine
Time frame: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 1
Time frame: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 2
Time frame: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 3
Time frame: Follow up to completion (48 weeks after intervention)
Urodynamic changes - 4
Time frame: Follow up to completion (48 weeks after intervention)
Quality of life monitoring - 1
Time frame: Follow up to completion (48 weeks after intervention)
Quality of life monitoring - 2
Time frame: Follow up to completion (48 weeks after intervention)
Bladder neck restenosis control
Time frame: Follow up to completion (48 weeks after intervention)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
Individual participant dataSharing planned: Undecided

Related trials for Bladder Neck Obstruction

Not yet recruiting
High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction
Bladder Outlet Obstruction, BPH
RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
Chronic Kidney Diseases, Bladder Dysfunction
RecruitingObservational study
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
Urinary Retention, Benign Prostate Obstruction (BPO)
Not yet recruiting
Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia, Bladder Outlet Obstruction
Recruiting
A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptom

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Denis V Butnaru, MD, PhD principal investigator

I.M. Sechenov First Moscow State Medical University

Andrey A Pulin, MD, PhD principal investigator

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 principal investigator

I.M. Sechenov First Moscow State Medical University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious adverse events (time frame: 4 weeks after injection of ADRC suspension). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02869061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.