Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 26 for:    stem cells AND male infertility

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762967
Recruitment Status : Enrolling by invitation
First Posted : December 4, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty"

Brief 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.

Condition or disease Intervention/treatment Phase
Azoospermia Oligozoospermia Biological: Lipoaspiration and SVF introduction. Drug: Standard therapy. Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study consist 40 patients in 4 groups. Two working groups and two control groups. Each group consist 10 Males.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency Evaluation of Adipose-Derived Adult Stromal Vascular Cells in Patients With Spermatogenesis Disorders.
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : November 13, 2018
Estimated Study Completion Date : December 30, 2019


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 Name: 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 Name: 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 Name: 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 Name: healthy diet, physical exertion eliminate. hormone therapy.




Primary Outcome Measures :
  1. 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.

  2. Spermatozoa in testicular biopsy [ Time Frame: 3 month ]
    Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.


Secondary Outcome Measures :
  1. Testosterone [ Time Frame: 3 month ]
    Testosterone will be measured a three month after injection of SVF.

  2. Inhibin-B [ Time Frame: 3 month ]
    Inhibin-B will be measured a three month after injection of SVF.

  3. Follicle stimulating hormone (FSH) [ Time Frame: 3 month ]
    Follicle stimulating hormone will be measured a three month after injection of SVF.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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….)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762967


Locations
Layout table for location information
Russian Federation
Medical Centre Dinasty
Samara, Russian Federation, 443095
Sponsors and Collaborators
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Investigators
Layout table for investigator information
Study Chair: Olga Tyumina, M.D. P.h.D. Medical Centre Dinasty

Layout table for additonal information
Responsible Party: Volchkov Stanislav, Deputy director, Quality assurance director, State-Financed Health Facility "Samara Regional Medical Center Dinasty"
ClinicalTrials.gov Identifier: NCT03762967     History of Changes
Other Study ID Numbers: 23032018
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty":
Autologous Stem Cell
Male infertility
Adipose-Derived stem cell
Azoospermia
Oligospermia
Additional relevant MeSH terms:
Layout table for MeSH terms
Azoospermia
Oligospermia
Infertility
Genital Diseases, Male
Infertility, Male
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs