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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Bladder Neck Obstruction
- Sponsor
- Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Serious adverse events
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
- •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
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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))
- Quality of life monitoring - 2(Follow up to completion (48 weeks after intervention))
- Changes of the volume of residual urine(Follow up to completion (48 weeks after intervention))
- Quality of life monitoring - 1(Follow up to completion (48 weeks after intervention))
- Bladder neck restenosis control(Follow up to completion (48 weeks after intervention))