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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Intra-Testicular Transplantation of Purified Autologous Clusters of Differentiation (CD) 34+,133+, and Mesenchymal Stem Cells for Treatment of Non-Obstructive Azoospermia

Brief Summary: This is an open label, single arm, single center investigation to assess the safety and efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and mesenchymal stem cells injected into the seminiferous tubules and testis, through a 12 week 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 retrieval of spermatogenesis, and the generation of mature spermatozoa. Expected outcomes of this study are defined in general improvements in infertile patients in regards of testicular morphology, sexual function, semen quality, development of primary or secondary spermatocytes, spermatids, or mature spermatozoa in the testis, seminiferous tubules, or semen.

Detailed Summary:

Non-obstructive azoospermia (NOA) is generally considered a non-medically manageable cause of male infertility. These patients, who constitute up to 10% of all infertile men, have abnormal spermatogenesis as the cause of their azoospermia. The etiology affecting approximately 60% of azoospermic men, includes non-obstructive causes of azoospermia, including toxic exposures or abnormal testicular development. NOA results from either primary testicular failure (elevated Luteinizing Hormone (LH), Follicle stimulating hormone (FSH), small testes affecting up to 10% of men presenting with infertility), secondary testicular failure (congenital hypogonadotropic hypogonadism with decreased LH and FSH, small testes), or incomplete or ambiguous testicular failure (either increased FSH and normal volume testes, normal FSH and small testes, or normal FSH and normal testis volume). Prior to microsurgical testicular sperm retrieval techniques and IVF/ICSI, donor insemination was the only option available to men with NOA. The establishment of in vitro fertilization using intracytoplasmic sperm injection (ICSI) as a standard treatment modality has resulted in a number of these men successfully fathering a child through surgically retrieved sperm from the testis. The challenge, however, is to improve their spermatogenic function to enable the appearance of sperm in their ejaculate or to improve the chances of a successful retrieval from the testis for ICSI.

The initial evaluation aims at resolving the following issues: (1) confirming azoospermia, (2) differentiating obstructive from non-obstructive etiology, (3) assessing for the presence of reversible factors and (4) evaluating for the presence of genetic abnormalities. An elevated follicle-stimulating hormone (FSH) level or an absence of normal spermatogenesis by testicular histology in the presence of azoospermia is generally considered
Sponsor: Stem Cells Arabia

Current Primary Outcome: Appearance of different germ cells in testicles through the progress of spermatogenesis will be assessed by the count of cells using histological studies. [ Time Frame: 12 months ]

Original Primary Outcome:

  • Development of primary or secondary spermatocytes in testicles will be assessed with histological studies. [ Time Frame: 12 months ]
  • Development of elongated spermatids in testicles will be assessed with histological studies. [ Time Frame: 12 months ]
  • Development of mature spermatozoa in testicles will be assessed with histological studies. [ Time Frame: 12 months ]


Current Secondary Outcome:

  • General improvements of testicular morphology will be assessed with histological studies. [ Time Frame: 12 months ]
  • Improvement in sexual function will be assessed using a questionnaire [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Stem Cells Arabia

Dates:
Date Received: December 7, 2015
Date Started: January 2014
Date Completion: January 2019
Last Updated: February 25, 2017
Last Verified: December 2015