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.
Infertile males with confirmed diagnosis of non-obstructive azoospermia (NOA)
Patients with Obstructive Azoospermia (OA)
Previous surgical history in Testis
Patients with infectious genital diseases
Patients with anatomical abnormalities of the genital tract
Single group
Stem Cell Transplantation
Biological/Vaccineintervention with transplantation of autologous purified stem cells
Appearance of spermatozoa in different maturation stages including primary spermatocytes, spermatids, and mature spermatozoa. Samples to be tested are either seminal fluid or testicular tissue obtained via fine needle aspiration (FNA) or surgical means.
General improvements of testicular morphology will be assessed with histological studies.
Improvement in sexual function will be assessed using a questionnaire
Click on the lead sponsor to view all of their trials.