A Phase 1/2 interventional study of Stem Cells in Male Infertility, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Al-Azhar University · Phase 1/2, Interventional, and Treatment
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.
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
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.
Also known as: Stem Cell Dose, 3-5 Million Autologous MSCs Injected into rete testis.
All Cases Improvement
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.
Time frame: One Year (12-Month)
All Cases Fertility Improvement
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.
Time frame: One Year (12-Month)
Plan to share: Yes
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Al-Azhar University