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