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Completed

NCT Number: NCT02025270

MSCs For Treatment of Azoospermic Patients

In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.

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Key information

Conditions

Male Infertility Azoospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Al Azhar University , School of Medicine

Cairo, 11884, Egypt

About this study

Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All Non obstructive Azoospermic Patients.
  • Azoospermic Patients due to Administration of Chemo/Radiotherapy.

Exclusion criteria

  • Patients with Testicular Cancer.
  • Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.

Treatment and study plan

stem cells

Biological

60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.

Other names: Stem Cell Dose, 3-5 Million Autologous MSCs Injected into rete testis.

Primary outcomes

  1. All Cases Improvement

    Time frame: One Year (12-Month)

    Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.

Secondary outcomes

  1. All Cases Fertility Improvement

    Time frame: One Year (12-Month)

    Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Cairo University

Registry information

Official study title

Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients

Important dates

Study start
2012
Primary completion
2016
Study completion
2022
First posted
Jan 1, 2014
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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