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

NCT ID: NCT02869061

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-12-31

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.

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

Study Design

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

Study Groups

ADRC injection

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.

Group Type: EXPERIMENTAL

Liposuction

Intervention Type: PROCEDURE

Transurethral bladder neck resection.

Intervention Type: PROCEDURE

ADRC

Intervention Type: BIOLOGICAL

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

ADRC isolation

Intervention Type: 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.

Interventions

Liposuction

Intervention Type: PROCEDURE

Transurethral bladder neck resection.

Intervention Type: PROCEDURE

ADRC

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

Intervention Type: BIOLOGICAL

ADRC isolation

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.

Intervention Type: OTHER

Other Intervention Names

Adipose-derived regenerative cells

Eligibility Criteria

Inclusion Criteria

• 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.)
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: collaborator

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis V Butnaru, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

I.M. Sechenov First Moscow State Medical University

Andrey A Pulin, MD, PhD

Role: 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

Role: PRINCIPAL_INVESTIGATOR

I.M. Sechenov First Moscow State Medical University

Locations

I.M. Sechenov First Moscow State Medical University

Moscow, , Russia

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

Moscow, , Russia

Countries

Russia

Other Identifiers

RU-CCH-01-02-15

Identifier Type: -

Identifier Source: org_study_id