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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02025270
Other study ID # AZH010066099
Secondary ID Azhar23052011
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 15, 2012
Est. completion date December 20, 2022

Study information

Verified date February 2023
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 20, 2022
Est. primary completion date October 15, 2016
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Stem Cells
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.

Locations

Country Name City State
Egypt Al Azhar University , School of Medicine Cairo

Sponsors (2)

Lead Sponsor Collaborator
Al-Azhar University Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary All Cases Improvement Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency. One Year (12-Month)
Secondary All Cases Fertility Improvement Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency. One Year (12-Month)
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