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

NCT02041910 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-01-22

No results posted yet for this study

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

Conditions

  • Azoospermia

Interventions

BIOLOGICAL

Stem Cells

MSCs injection intratesticular

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.

Sponsors & Collaborators

  • Hesham Saeed Elshaer

    lead OTHER

Principal Investigators

  • Taimour Khalifa, MD · Al-Azhar University

  • Sayed Bakry, PhD · Al-Azhar University

  • Hala Gabr, MD · Cairo University

  • Wael Abu El Khier, MD · Military Academy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-01-31
Completion
2015-03-31

Countries

  • Egypt

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02041910 on ClinicalTrials.gov