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| Name | Class |
|---|---|
| I.M. Sechenov First Moscow State Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADRC injection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction | Procedure |
| ||
| Transurethral bladder neck resection. |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events | Frequency, type and severity of serious adverse events (SAE) | 4 weeks after injection of ADRC suspension |
| Serious adverse reactions | Frequency, type and severity of serious adverse reactions (SAR) | Time Frame: 4 weeks after injection of ADRC suspension |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Urodynamic changes - 1 |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis V Butnaru, MD, PhD | I.M. Sechenov First Moscow State Medical University | Principal Investigator |
| Andrey A Pulin, MD, PhD | Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation | Principal Investigator |
| Andrey Z Vinarov, MD, PhD, Prof | I.M. Sechenov First Moscow State Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University | Moscow | 119991 | Russia | |||
| Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation |
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| Procedure |
|
| ADRC | Biological | Injection of ADRC suspension will be performed endoscopically into the bladder neck close to the site of resection. |
|
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| ADRC isolation | Other | 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. |
|
Influence of the intervention on urinary flow rate: maximum flow rate
| Follow up to completion (48 weeks after intervention) |
| Urodynamic changes - 2 | Influence of the intervention on urinary flow rate: average flow rate | Follow up to completion (48 weeks after intervention) |
| Urodynamic changes - 3 | Influence of the intervention on urinary flow rate: total volume voided | Follow up to completion (48 weeks after intervention) |
| Urodynamic changes - 4 | Influence of the intervention on urinary flow rate: maximum flow time | Follow up to completion (48 weeks after intervention) |
| 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) |
| 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) |
| Bladder neck restenosis control | Revision of bladder neck structure by retrograde urethrography | Follow up to completion (48 weeks after intervention) |
| Moscow |
| 121359 |
| Russia |
| ID | Term |
|---|---|
| D001748 | Urinary Bladder Neck Obstruction |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D052801 | Male Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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