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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02869061
• Other study ID #: RU-CCH-01-02-15
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: August 8, 2016
• Last updated: August 11, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical 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. This is a single arm study with no control. All patients receive cell therapy.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Non-inclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Bladder Neck Obstruction
• Bladder Outlet Obstruction
• Contracture
• Hyperplasia
• Prostatic Hyperplasia
• Torticollis
• Urinary Bladder Neck Obstruction

Intervention

Procedure:
• Liposuction

• Transurethral bladder neck resection.

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

Other:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati	I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious adverse events	Frequency, type and severity of serious adverse events (SAE)	4 weeks after injection of ADRC suspension	Yes
Primary	Serious adverse reactions	Frequency, type and severity of serious adverse reactions (SAR)	Time Frame: 4 weeks after injection of ADRC suspension	Yes
Secondary	Changes of the volume of residual urine	Influence of the procedure on the volume of residual urine assessed by ultrasonography	Follow up to completion (48 weeks after intervention)	No
Secondary	Urodynamic changes - 1	Influence of the intervention on urinary flow rate: maximum flow rate	Follow up to completion (48 weeks after intervention)	No
Secondary	Urodynamic changes - 2	Influence of the intervention on urinary flow rate: average flow rate	Follow up to completion (48 weeks after intervention)	No
Secondary	Urodynamic changes - 3	Influence of the intervention on urinary flow rate: total volume voided	Follow up to completion (48 weeks after intervention)	No
Secondary	Urodynamic changes - 4	Influence of the intervention on urinary flow rate: maximum flow time	Follow up to completion (48 weeks after intervention)	No
Secondary	Quality of life monitoring - 1	Quality of life estimated by validated questionnaire: the Short Form (SF-36).	Follow up to completion (48 weeks after intervention)	No
Secondary	Quality of life monitoring - 2	Quality of life estimated by validated questionnaire: International Prostatic Symptom Score (IPSS).	Follow up to completion (48 weeks after intervention)	No
Secondary	Bladder neck restenosis control	Revision of bladder neck structure by retrograde urethrography	Follow up to completion (48 weeks after intervention)	No