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

October 20, 2020 updated by: Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty"

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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….)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lipoaspiration and SVF introduction I.
Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
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.
Other Names:
  • healthy diet, physical exertion eliminate. hormone therapy.
Active Comparator: Standard therapy I.
Patients with azoospermia that introduce with Standard therapy only.
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.
Other Names:
  • healthy diet, physical exertion eliminate. hormone therapy.
Experimental: Lipoaspiration and SVF introduction II
Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
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.
Other Names:
  • healthy diet, physical exertion eliminate. hormone therapy.
Active Comparator: Standard therapy II.
Patients with oligospermia that introduce with Standard therapy only.
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.
Other Names:
  • healthy diet, physical exertion eliminate. hormone therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sperm concentration in ejaculate
Time Frame: 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.
1, 2, 3 month
Spermatozoa in testicular biopsy
Time Frame: 3 month
Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testosterone
Time Frame: 3 month
Testosterone will be measured a three month after injection of SVF.
3 month
Inhibin-B
Time Frame: 3 month
Inhibin-B will be measured a three month after injection of SVF.
3 month
Follicle stimulating hormone (FSH)
Time Frame: 3 month
Follicle stimulating hormone will be measured a three month after injection of SVF.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Olga Tyumina, M.D. P.h.D., Medical Centre Dinasty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2018

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23032018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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