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
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Serious adverse events
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Serious adverse events
时间窗: 4 weeks after injection of ADRC suspension
Frequency, type and severity of serious adverse events (SAE)
Serious adverse reactions
时间窗: Time Frame: 4 weeks after injection of ADRC suspension
Frequency, type and severity of serious adverse reactions (SAR)
次要结局
- 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))