Efficiency Evaluation of Adipose-Derived Adult Stromal Vascular Cells in Patients With Spermatogenesis Disorders.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Spermatozoa in testicular biopsy
研究概览
简要总结
Severe Oligospermia (oligozoospermia) refer to semen with a low concentration of sperm and is a common finding in male infertility. Often semen with a decreased sperm concentration may also show significant abnormalities in sperm morphology and motility that affect Male fertility. The purpose of this study is to assess the ability of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) cells to stimulate Sertoli and spermatogonia cells and affect male fertility.
详细描述
This is an open-label study to evaluate efficiency of administration of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) in the testis in patients with oligospermia and azoospermia.
Forty men with several form oligozoospermia and azoospermia will be recruited for the study. 20 patients with same diagnosis served as a control with standard medications.Other patients -10 with oligospermia and 10 with azoospermia will receive standard medication and SVF injections.
The diagnosis of Azoospermia (Oligospermia) will be established on the basis of two and more semen analysis evaluations done at separate occasions and detailed history taking, physical examination and investigations (blood tests include hormon levels as testosteron. follicle stimulating hormone (FSH), luteinizing hormone (LH). karyotyping and testosterone levels, and may include testicular biopsy or transrectal ultrasound if indicated.
This study affect only Pretesticular and Testicular forms, without chromosomal aberration. SVF can produce a lot of cytokines ( as EGF, FGF, NGF, PDGF, VEGF, IGF, GMCSF, GCSF, TGF, Erythropoetin, TPO, BMP, HGF, GDF, Neurotrophins, MSF, SGF, GDF and growth factors) moreover the microvesicles and exosomes released by this cells can prevent cells from apoptosis and stimulate regenerative process of surrounding tissues and cells.
SVF will be transplanted by an andrological surgeon through a standard surgical approach. Subjects will be monitored frequently for a total of one year after cell injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •idiopathic oligozoospermia (spermatozoid number <2x10^6/mL) - 10 patients
- •cryptozoospermia/azoospermia - 10 patients
排除标准
- •age before 18 or after 60 years old
- •heart insufficiency. stroke (during 1 year)
- •blood disease
- •pelvis bone trauma
- •chronic diseases in decompensation stage
- •skin diseases
- •tuberculosis
- •hyperprolactinaemia
- •hyper or hypothyreosis
- •obstructive zoospermia
- •sperm stimulating hormone therapy
- •Men with previous surgery in testis
- •Men with infectious genital diseases and anatomical abnormalities of the genital tract
- •Those with major medical problems such as malignancy, hepatitis B . C, etc. HIV
- •Chromosomal aberration (e.g. Y microdeletion, trisomy....)
研究组 & 干预措施
Lipoaspiration and SVF introduction II
Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
干预措施: Lipoaspiration and SVF introduction. (Biological)
Lipoaspiration and SVF introduction I.
Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
干预措施: Lipoaspiration and SVF introduction. (Biological)
Lipoaspiration and SVF introduction I.
Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
干预措施: Standard therapy. (Drug)
Standard therapy I.
Patients with azoospermia that introduce with Standard therapy only.
干预措施: Standard therapy. (Drug)
Lipoaspiration and SVF introduction II
Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
干预措施: Standard therapy. (Drug)
Standard therapy II.
Patients with oligospermia that introduce with Standard therapy only.
干预措施: Standard therapy. (Drug)
结局指标
主要结局
Spermatozoa in testicular biopsy
时间窗: 3 month
Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.
sperm concentration in ejaculate
时间窗: 1, 2, 3 month
Sperm quantity and quality will be evaluated with automatic sperm cout analyzer a month, two and three after injection of SVF. Total measures - 3.
次要结局
- Inhibin-B(3 month)
- Testosterone(3 month)
- Follicle stimulating hormone (FSH)(3 month)
研究者
Volchkov Stanislav
Deputy director, Quality assurance director
State-Financed Health Facility "Samara Regional Medical Center Dinasty"