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MSCs For Treatment of Azoospermic Patients

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02025270
Enrollment
100
Registered
2014-01-01
Start date
2012-10-15
Completion date
2022-12-20
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Keywords

Azoospermia, Spermatogonial Arrest, Maturation Arrest.

Brief 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.

Detailed 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.

Interventions

BIOLOGICALStem 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.

Sponsors

Cairo University
CollaboratorOTHER
Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All Cases ImprovementOne Year (12-Month)Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.

Secondary

MeasureTime frameDescription
All Cases Fertility ImprovementOne Year (12-Month)Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026