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

Azoospermia Clinical Trial

Official title:

Efficiency Evaluation of Adipose-Derived Adult Stromal Vascular Cells in Patients With Spermatogenesis Disorders.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03762967
• Other study ID #: 23032018
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: March 12, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2020
• Source: State-Financed Health Facility "Samara Regional Medical Center Dinasty"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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….)

Related Conditions & MeSH terms

• Azoospermia
• Oligospermia
• Oligozoospermia

Intervention

Biological:
• Lipoaspiration and SVF introduction.
Lipoaspiration, isolation of SVF and introduction into testis Interstitium.

Drug:
• Standard therapy.
Standard therapy include to give up bad habits, to establish a healthy diet, to eliminate excessive physical exertion. eliminate. In the case of endocrine disorders, hormone therapy is prescribed.

Locations

Country	Name	City	State
Russian Federation	Medical Centre Dinasty	Samara

Sponsors (1)

Lead Sponsor	Collaborator
State-Financed Health Facility "Samara Regional Medical Center Dinasty"

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sperm concentration in ejaculate	Sperm quantity and quality will be evaluated with automatic sperm cout analyzer a month, two and three after injection of SVF. Total measures - 3.	1, 2, 3 month
Primary	Spermatozoa in testicular biopsy	Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.	3 month
Secondary	Testosterone	Testosterone will be measured a three month after injection of SVF.	3 month
Secondary	Inhibin-B	Inhibin-B will be measured a three month after injection of SVF.	3 month
Secondary	Follicle stimulating hormone (FSH)	Follicle stimulating hormone will be measured a three month after injection of SVF.	3 month