MSCs For Treatment of Azoospermic Patients

Al-Azhar University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Male Infertility

Treatments: Biological: Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02025270

AZH010066099

Azhar23052011 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 1 patient group

Laboratory and Clinical

Other group

Description:

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 rete testis.

Treatment:

Biological: Stem Cells