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

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.

Timeline

Start

2014-01

Primary completion

2030-06

Completion

2031-01

Drugs

Indications