Effectiveness and Safety of Intracavernosal Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Erectile Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- SAEs monitoring
研究概览
简要总结
Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time intracavernosally. 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:
Aspirated fat tissue placed into sterile vessel which inserted into Celution 800/CRS System (Cytori Therapeutics Inc) - closed system for automated and standardized extraction and concentration of ADRC. Celution 800/CRS System drains excess of fluid from fat tissue and estimate it's volume After that lipoaspirate washed extensively with equal volumes of Ringer's solution to remove blood. At the end of this process System indicates required volume of enzyme reagent (Celase®) which should be added immediately by operator. After enzyme treatment Celution 800/CRS System automatically transfers isolated ADRC into washing compartment where ADRC washed and concentrated in 5 mL suspension. Tissue processing time - approximately 60 minutes. ADRC suspension match all requirements listed in technical documentation for Celution 800/CRS System. Obtained ADRC divided into 2 portions. First portion (0.2-0.5 mL) used for counting, viability and sterility assessment. Second portion placed into sterile insulin syringes with needle size 30 G for injection.
Intracavernosal injection of ADRC:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient suffers from erectile dysfunction
- •IIEF-5 score less than 21
- •Endothelial dysfunction confirmed by EndoPAT measurements
- •Patient is familiar with Participant information sheet
- •Patient signed informed consent form
- •Non-inclusion Criteria:
- •Contraindications to the local anesthesia or medical history of allergic reactions to local anesthetics
- •Patient prescribed for systemic corticosteroids, immunosuppressive drugs, nonsteroidal antiinflammatory drugs, phosphodiesterase-5 inhibitors
- •Medical history of penile prosthesis implantation
- •Peyronie's disease
- •Subcompensated or decompensated forms of chronic diseases of internal organs
- •Clinically significant abnormalities in results of laboratory tests
- •Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and 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.
- •Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
- •Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior liposuction
- •Medical history of heterotopic ossifications
- •Patients prescribed for glycoprotein inhibitors treatment
- •Patients with infections or septic condition
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
- •Patients with hypogonadism
- •Dropout Criteria:
- •Direct indications on immediate initiation of treatment with drugs that have proven effect on erectile function
结局指标
主要结局
SAEs monitoring
时间窗: 2 weeks after treatment
Types, probability and severity of treatment emergent serious adverse events (SAEs)
SARs monitoring
时间窗: 2 weeks after treatment
Types, probability and severity of treatment emergent serious adverse reactions (SARs)
次要结局
- Endothelial function assessment(Follow up to completion (up to 24 weeks after treatment))
- Arterial stiffness assessment(Follow up to completion (up to 24 weeks after treatment))
- Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection(Follow up to completion (up to 24 weeks after treatment))
- Quality of life monitoring(Follow up to completion (up to 24 weeks after treatment))