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Clinical trial

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

ID
Name
AZH010066099
Description
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.
Trial arms
Trial start
2012-10-15
Estimated PCD
2016-10-15
Trial end
2022-12-20
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Laboratory and Clinical
Other names:
Stem Cell Dose, 3-5 Million Autologous MSCs Injected into rete testis.
Size
100
Primary endpoint
All Cases Improvement
One Year (12-Month)
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-03-01

1 organization

1 product

1 indication

Organization
Al-Azhar University
Product
Stem Cells
Indication
Male Infertility