MSCs For Treatment of Azoospermic Patients

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025270
• Other study ID #: AZH010066099
• Secondary ID: Azhar23052011
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

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)