NCT02869061

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation · Other Government
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Liposuction
PROCEDURE	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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2016-08-16
• Last updated: 2016-08-16

Locations

2 sites across 1 country: Russia