Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture
Bladder Neck Obstruction, Bladder Outlet Obstruction, Benign Prostatic Hyperplasia
About this trial
This is an interventional prevention trial for Bladder Neck Obstruction focused on measuring 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
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
- 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
Sites / Locations
- I.M. Sechenov First Moscow State Medical University
- Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Arms of the Study
Arm 1
Experimental
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.