Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Testicular Injection of Autologous Stem Cells for Treatment of Patients With Azoospermia

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: NCT02041910
Recruitment Status : Unknown
Verified January 2014 by Hesham Saeed Elshaer, El-Rayadh Fertility Centre.
Recruitment status was:  Recruiting
First Posted : January 22, 2014
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Hesham Saeed Elshaer, El-Rayadh Fertility Centre

Brief Summary:
Azoospermia is defined as the complete lack of sperm in the ejaculate. In humans, Azoospermia affects about 1% of the male population and may be seen in up to 20% of male infertility situations. In testicular Azoospermia the testes are abnormal, atrophic, or absent, and sperm production severely disturbed to absent. FSH levels tend to be elevated (hypergonadotropic) as the feedback loop is interrupted. The condition is seen in 49-93% of men with Azoospermia. The purpose of this study is to assess the ability of bone marrow derived stem cells to differentiate into germ cells and their role in treatment of testicular Azoospermia

Condition or disease Intervention/treatment Phase
Azoospermia Biological: Stem Cells Phase 1 Phase 2

Detailed Description:

This study is an open-label investigation of the efficacy of injection autologous adult bone marrow derived stem cells into the somniferous tubules or interstitial spaces of male testis with Azospermia. Sixty men with Azoospermia will be recruited in this study after a written informed consent.

The diagnosis of Azoospermia will be established on the basis of two semen analysis evaluations done at separate occasions; this will be followed by detailed history taking, physical examination and investigations. History taking will include general health, sexual health, past fertility, libido, sexual activity and previous exposure to surgery, drugs, mumps infection and irradiation. Physical examination includes genital and local examination for detection of signs of Klinefelter syndrome, testicular atrophy, absence of vas. Investigations include serum FSH, LH, karyotyping and testosterone levels, and may include testicular biopsy or transrectal ultrasound if indicated (Low levels of LH and FSH with low or normal testosterone levels are indicative of pretesticular problems, while high levels of gonadotropins indicate testicular problems. However, often this distinction is not clear and the differentiation between obstructive versus non-obstructive Azoospermia may require a testicular biopsy).

Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals. Human adult bone marrow derived stem cells will be transplanted by an andrological surgeon through a standard surgical approach. Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection. For safety of participants, Bone Marrow Stem cells will be injected in one testis only and the other testis will be spared.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testicular Injection of Autologous Human Bone Marrow Derived Stem Cells for Treatment of Patients With Azoospermia
Study Start Date : January 2014
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: Stem Cells
60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into testis.
Biological: Stem Cells
MSCs injection intratesticular
Other Name: MSCs

Experimental: Stem Cells Injection
Stem Cell Dose 3-5 Million Autologous MSCs Injected into testis.
Biological: Stem Cells
60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into testis.




Primary Outcome Measures :
  1. Cases Improvement [ Time Frame: 12 Weeks ]

    Serum Hormonal Profile:

    (elevation of testosterone levels, decreasing of FSH, LH and Prolactine Levels); Testicular Size (increased size); and Sexual Potency (increased sexual potency).



Secondary Outcome Measures :
  1. Cases Improvement [ Time Frame: 48 Weeks ]
    Testicular biopsy



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:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with non-obstructive Azoospermia
  • Patients between 25 - 60 years old.

Exclusion Criteria:

  • Patients with obstructive Azoospermia
  • 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, etc.
  • Chromosomal aberration (e.g. Y microdeleion, 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): NCT02041910


Contacts
Layout table for location contacts
Contact: Hesham El Shaer, MD +201223130881 dr.heshamelshaer@hotmail.com

Locations
Layout table for location information
Egypt
El-Rayadh Fertility Center Recruiting
Al Mohandseen, Giza, Egypt
Contact: Hesham El Shaer, MD    +201223130881    dr.heshamelshaer@hotmail.com   
Sub-Investigator: Prof. Dr. Hesham Elshaer, MD         
Sponsors and Collaborators
Hesham Saeed Elshaer
Investigators
Layout table for investigator information
Principal Investigator: Taimour Khalifa, MD Al-Azhar University
Study Director: Sayed Bakry, PhD Al-Azhar University
Study Chair: Hala Gabr, MD Cairo University
Study Chair: Wael Abu El Khier, MD Military Academy

Layout table for additonal information
Responsible Party: Hesham Saeed Elshaer, Associate Professor & Director, El-Rayadh Fertility Centre
ClinicalTrials.gov Identifier: NCT02041910    
Other Study ID Numbers: NCT0550330
RFC0550330 ( Other Grant/Funding Number: RayadhFC0550330 )
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Azoospermia
Infertility, Male
Infertility
Genital Diseases, Male