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

Azoospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02041910
• Other study ID #: NCT0550330
• Secondary ID: RFC0550330
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 10, 2014
• Last updated: January 18, 2014
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: January 2014
• Source: El-Rayadh Fertility Centre
• Contact: Hesham El Shaer, MD
• Phone: +201223130881
• Email: dr.heshamelshaer[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Azoospermia

Intervention

Biological:
• Stem Cells
MSCs injection intratesticular
• 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.

Locations

Country	Name	City	State
Egypt	El-Rayadh Fertility Center	Al Mohandseen	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Hesham Saeed Elshaer

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cases Improvement	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	Yes
Secondary	Cases Improvement	Testicular biopsy	48 Weeks	Yes