Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- All Cases Improvement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
Laboratory and Clinical
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.
Intervention: Stem Cells (Biological)
Outcomes
Primary Outcomes
All Cases Improvement
Time Frame: One Year (12-Month)
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.
Secondary Outcomes
- All Cases Fertility Improvement(One Year (12-Month))
Investigators
Sayed Bakry
Associate Professor , Consultant of Separation and Culturing of Stem Cells
Al-Azhar University