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

NCT02869061 | Unknown Phase 1

• 1 other identifier: RU-CCH-01-02-15
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• Serious adverse events

  Frequency, type and severity of serious adverse events (SAE)

  4 weeks after injection of ADRC suspension

• Serious adverse reactions

  Frequency, type and severity of serious adverse reactions (SAR)

  Time Frame: 4 weeks after injection of ADRC suspension

Secondary Outcomes (8)

• Changes of the volume of residual urine

  Follow up to completion (48 weeks after intervention)

• Urodynamic changes - 1

  Follow up to completion (48 weeks after intervention)

• Urodynamic changes - 2

  Follow up to completion (48 weeks after intervention)

• Urodynamic changes - 3

  Follow up to completion (48 weeks after intervention)

• Urodynamic changes - 4

  Follow up to completion (48 weeks after intervention)

Study Arms (1)

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.

Procedure: Liposuction; Procedure: Transurethral bladder neck resection.; Biological: ADRC; Other: ADRC isolation

Interventions

Liposuction PROCEDURE

ADRC injection

Transurethral bladder neck resection. PROCEDURE

ADRC injection

ADRC BIOLOGICAL

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

Also known as: Adipose-derived regenerative cells

ADRC injection

ADRC isolation OTHER

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.

ADRC injection

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation: lead
• I.M. Sechenov First Moscow State Medical University: collaborator

Study Sites (2)

I.M. Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

Moscow, 121359, Russia

Location

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction; Prostatic Hyperplasia

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Denis V Butnaru, MD, PhD

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

• 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

  PRINCIPAL INVESTIGATOR

• Andrey Z Vinarov, MD, PhD, Prof

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 16, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

RU (2)