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

NCT ID: NCT02041910

Last Updated: 2014-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-03-31

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

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.

Conditions

Azoospermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stem Cells

Intervention Type: BIOLOGICAL

MSCs injection intratesticular

Stem Cells Injection

Stem Cell Dose 3-5 Million Autologous MSCs Injected into testis.

Group Type: EXPERIMENTAL

Stem Cells

Intervention Type: BIOLOGICAL

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.

Interventions

Stem Cells

MSCs injection intratesticular

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

MSCs

Eligibility 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….)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hesham Saeed Elshaer

OTHER

Sponsor Role: lead

Responsible Party

Hesham Saeed Elshaer

Associate Professor & Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Taimour Khalifa, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Sayed Bakry, PhD

Role: STUDY_DIRECTOR

Al-Azhar University

Hala Gabr, MD

Role: STUDY_CHAIR

Cairo University

Wael Abu El Khier, MD

Role: STUDY_CHAIR

Military Academy

Locations

El-Rayadh Fertility Center

Al Mohandseen, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hesham El Shaer, MD

Role: CONTACT

dr.heshamelshaer@hotmail.com

+201223130881

Facility Contacts

Hesham El Shaer, MD

Role: primary

dr.heshamelshaer@hotmail.com

+201223130881

Other Identifiers

RFC0550330

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCT0550330

Identifier Type: -

Identifier Source: org_study_id