A Study of Therapeutic Spermatogonial Differentiation for Infertile Men Via Testicular Organoid
CellARTs Inc.
Summary
Purpose: This clinical trial aims to explore the potential for human sperm production in vitro by sustaining a laboratory-cultured adult testicular environment. It also seeks to identify genetic factors contributing to human sterility and failed spermatogenesis. The study's primary objectives include: 1. Identifying genomic markers associated with sterility and failed spermatogenesis. 2. Developing an ex vivo (outside the body) testis "organ-on-a-chip" ("iTestis") to support stem cell cultivation. 3. Determining whether human spermatogenesis can be re-created in vitro using stem cells nurtured in the iTestis model. Study Description: Researchers will analyze the genomic profiles of fertile and sterile male participants to map genetic abnormalities associated with sterility. Using testicular and skin tissue samples from participants, spermatogonial stem cells and pluripotent stem cells will be isolated and utilized to construct the ex vivo iTestis. This system will integrate genomic insights and prior research to foster human spermatogenesis outside the body. Participant Involvement: Participants will provide the following samples: * Blood sample for serum analysis. * A skin tissue biopsy. * Testicular tissue, obtained through fine needle aspiration (FNA) or testicular sperm extraction (TESE), as part of a routine procedure. All procedures will be conducted by the principal investigator and qualified research staff, ensuring participant safety and adherence to ethical guidelines.
Eligibility
- Age range
- 18–60 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: Group 1 (Fertile Control) * Male sex of reproductive age (between 18 - 60 years old). * Evidence of fertility or normal spermatogenesis. * Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes. Inclusion Criteria: Group 2 and 3 (Infertile) * Male sex of reproductive age (between 18 - 60 years old). * Males with evidence of \>1 year of infertility. * Posesses diagnosis of azoospermia is on clinical evaluation. * Will undergo study procedures in conjunction with their planned fertility or inferti…
Interventions
- GeneticStem cell
Primary cell cultures of tissue cells will be established. Cell cultures will undergo genetic reprogramming to induce the long-term propagation of living cells.
- GeneticGenetic Screening
Serum samples are processed through RNA sequencing to reveal known and novel infertility-related biomarkers and genes.
- GeneticGenetic Reprogramming
Genes or gene products will be reinserted into cells to observe how the cells can be changed, or reprogrammed, into embryonic-like cells or into sperm precursor cells.
- GeneticCell Maturation
Genetically unmodified and modified cells are placed in a laboratory-based testicular environment to promote spermatogenesis into maturity.
Location
- The Turek ClinicSan Francisco, California