Autologous Adipose-Derived Adult Stromal Vascular Cell Administration for Male Patients With Infertility

State-Financed Health Facility "Samara Regional Medical Center Dinasty"

Status and phase: Unknown; Phase 2

Conditions: Azoospermia; Oligozoospermia

Treatments: Biological: Lipoaspiration and SVF introduction.; Drug: Standard therapy.

Study type: Interventional

Funder types: Other

Identifiers

NCT03762967

23032018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• idiopathic oligozoospermia (spermatozoid number <2x10^6/mL) - 10 patients
• cryptozoospermia/azoospermia - 10 patients

Exclusion criteria

• age before 18 or after 60 years old
• heart insufficiency. stroke (during 1 year)
• anemia
• 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....)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Lipoaspiration and SVF introduction I.

Experimental group

Description:

Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.

Treatment:

Drug: Standard therapy.

Biological: Lipoaspiration and SVF introduction.

Standard therapy I.

Active Comparator group

Description:

Patients with azoospermia that introduce with Standard therapy only.

Treatment:

Drug: Standard therapy.

Lipoaspiration and SVF introduction II

Experimental group

Description:

Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.

Treatment:

Drug: Standard therapy.

Biological: Lipoaspiration and SVF introduction.

Standard therapy II.

Active Comparator group

Description:

Patients with oligospermia that introduce with Standard therapy only.

Treatment:

Drug: Standard therapy.