MSCs For Treatment of Azoospermic Patients
- Conditions
- Male Infertility
- Interventions
- Biological: Stem Cells
- Registration Number
- NCT02025270
- Lead Sponsor
- Al-Azhar University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 100
- All Non obstructive Azoospermic Patients.
- Azoospermic Patients due to Administration of Chemo/Radiotherapy.
- Patients with Testicular Cancer.
- Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Laboratory and Clinical Stem Cells 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.
- Primary Outcome Measures
Name Time Method All Cases Improvement One Year (12-Month) Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.
- Secondary Outcome Measures
Name Time Method All Cases Fertility Improvement One Year (12-Month) Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.
Trial Locations
- Locations (1)
Al Azhar University , School of Medicine
🇪🇬Cairo, Egypt