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RECRUITING
NCT02641769
PHASE1/PHASE2

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

Sponsor: Stem Cells Arabia

View on ClinicalTrials.gov

Summary

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.

Official title: Intra-Testicular Transplantation of Purified Autologous None Marrow-Derived, Highly Specialized Cellular Populations, and Mesenchymal Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility. Patients Diagnosed With Any of the Following Might Benefit: Sertoli Cell Only Syndrome (SCOS), Maturation Arrest, Post- Chemotherapy, Small Testes, Cystic Fibrosis Obstructive Azoospermia, Post-hormonal Therapy,

Key Details

Gender

MALE

Age Range

21 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2014-01

Completion Date

2031-01

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

BIOLOGICAL

Stem Cell Transplantation

intervention with transplantation of autologous purified stem cells

Locations (1)

Stem Cells of Arabia

Amman, Amman Governorate, Jordan