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NCT02025270

MSCs For Treatment of Azoospermic Patients

Completed Phase 1, PHASE2 Last updated 1 March 2023
What this trial tests

Phase 1, PHASE2 trial testing Stem Cells in Male Infertility in 100 participants. Completed in 20 December 2022.

Timeline
15 October 2012
Primary endpoint
15 October 2016
20 December 2022

Quick facts

Lead sponsorAl-Azhar University
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingsingle
Primary purposetreatment
Enrollment100
Start date15 October 2012
Primary completion15 October 2016
Estimated completion20 December 2022
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Al-Azhar University

Who can join

Adults 20 to 50, male only, with Male Infertility. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Application of Stem Cell Therapy for Infertility.
    Saha S, Roy P, Corbitt C, Kakar SS. · · 2021 · cited 54× · PMID 34203240 · DOI 10.3390/cells10071613
  2. Mesenchymal stromal/stem cells and their exosomes for restoration of spermatogenesis in non-obstructive azoospermia: a systemic review.
    Zhankina R, Baghban N, Askarov M, Saipiyeva D, et al · · 2021 · cited 49× · PMID 33823925 · DOI 10.1186/s13287-021-02295-9
  3. Cellular Therapy via Spermatogonial Stem Cells for Treating Impaired Spermatogenesis, Non-Obstructive Azoospermia.
    Abdelaal NE, Tanga BM, Abdelgawad M, Allam S, et al · · 2021 · cited 19× · PMID 34359947 · DOI 10.3390/cells10071779
  4. Emerging Landscape of Mesenchymal Stem Cell Senescence Mechanisms and Implications on Therapeutic Strategies.
    Wang J, Zhang M, Wang H. · · 2024 · cited 13× · PMID 39144566 · DOI 10.1021/acsptsci.4c00284
  5. Cell-Based Therapy Approaches in Treatment of Non-obstructive Azoospermia.
    Roshandel E, Mehravar M, Nikoonezhad M, Alizadeh AM, et al · · 2023 · cited 6× · PMID 36380137 · DOI 10.1007/s43032-022-01115-6
  6. Effects of clinical medications on male fertility and prospects for stem cell therapy.
    Mo P, Zhao Z, Ke X, Fan Y, et al · · 2023 · cited 5× · PMID 37791073 · DOI 10.3389/fcell.2023.1258574
  7. Improving Fertility in Non-obstructive Azoospermia: Results from an Autologous Bone Mar-row-Derived Mesenchymal Stromal/Stem Cell Phase I Clinical Trial.
    Zhankina R, Zhanbyrbekuly U, Askarov M, Zare A, et al · · 2024 · cited 4× · PMID 39033372 · DOI 10.22074/ijfs.2023.2005045.1480
  8. Research progress on the mechanism underlying the application of mesenchymal stem cells in the treatment of male infertility.
    Tian X, Zhang J, Tang X, Guo X, et al · · 2025 · PMID 41019344 · DOI 10.3389/fendo.2025.1671247

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