Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility.

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-obstructive Azoospermia

In brief

This is an open label, single arm, single center investigation to assess the safety and efficacy of purified adult autologous, bone marrow derived, highly specialized, differentiation specific into spermatogonial lineages, and mesenchymal stem cells injected into the seminiferous tubules and testis, through a 24-month follow-up period. The investigators' selected model of research is based on maximizing the efficiency of the approach by choosing an autologous pattern which preserves the genetic make-up of an individual that is vital in infertility conditions. Additionally, the approach involves injecting a combination of different but purified cell types which all aid in the re-establishment of spermatogenesis, and the generation of mature spermatozoa. Expected outcomes of this study are defined in general improvements in infertile patients with regards to testicular morphology, sexual function, semen quality, development of primary or secondary spermatocytes, spermatids, or mature spermatozoa in the testis, seminiferous tubules, or semen.

Key facts

Study ID

NCT02641769

Run by

Stem Cells Arabia

People needed

600

Starts

2014-01-01

Expected to finish

2031-01-01

Last updated by the study team

2026-07-01

Who can join

Age: 21 and older, up to 50. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Infertile males with confirmed diagnosis of non-obstructive azoospermia (NOA)

You may not qualify if…

• Patients with Obstructive Azoospermia (OA)
• Previous surgical history in Testis
• Patients with infectious genital diseases
• Patients with anatomical abnormalities of the genital tract
• Patients with major medical problems as malignancies
• Chromosomal aberration (e.g. Y microdeletion, trisomy….)

Where it is running

• Stem Cells of Arabia — Amman, Amman Governorate, Jordan (enrolling)

Full record on ClinicalTrials.gov

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