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

January 18, 2014 updated by: Hesham Saeed Elshaer

Testicular Injection of Autologous Human Bone Marrow Derived Stem Cells for Treatment of Patients With Azoospermia

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
    • Giza
      • Al Mohandseen, Giza, Egypt
        • Recruiting
        • El-Rayadh Fertility Center
        • Contact:
        • Sub-Investigator:
          • Prof. Dr. Hesham Elshaer, MD

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

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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….)

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • MSCs
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.
Experimental: Stem Cells Injection
Stem Cell Dose 3-5 Million Autologous MSCs Injected into testis.
Biological: Stem Cells
MSCs injection intratesticular
Other Names:
  • MSCs
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cases Improvement
Time Frame: 48 Weeks
Testicular biopsy
48 Weeks

Collaborators and Investigators

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

Sponsor

Hesham Saeed Elshaer

Investigators

  • 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

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

January 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 18, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 18, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT0550330
  • RFC0550330 (Other Grant/Funding Number: RayadhFC0550330)

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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