Spermatogonial Differentiation Via Testicular Organoid

Purpose

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.

Conditions

  • Infertility, Male
  • Gene Abnormality
  • Sterility, Male

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
Male
Accepts 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 infertility procedures performed for clinical purposes.

Exclusion Criteria

  • The lack of diagnosis of fertility or infertility, and lack of testicles.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
All participants will be donating human tissue serum (blood), skin (via biopsy), and testicular tissue (via biopsy). These samples will be used for: 1. Primary cell culture of tissue cells will be established and genetic reprogramming could be applied to induce the long-term propagation of living cells. 2. Characterization and genetic screening of cells will be done to discover and reveal known or novel infertility-related biomarkers or genes. 3. Genetic reprogramming. Certain genes or gene products are inserted into donated cells to study how the cells can be changed, or reprogrammed, into embryonic-like cells or into sperm precursor cells. 4. Culture of cells in testicular organoids. Genetically unmodified or modified cells from donated samples could be placed in a laboratory-based testicular environment to see if sperm can be made.
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Fertile Males 		Fertile male participants (control group) with no known infertility conditions undergoing a vasectomy reversal. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
  • Genetic: Stem 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.
  • Genetic: Genetic Screening
    Serum samples are processed through RNA sequencing to reveal known and novel infertility-related biomarkers and genes.
    Other names:
    • genome mapping
    • genome characterization
  • Genetic: Genetic 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.
  • Genetic: Cell Maturation
    Genetically unmodified and modified cells are placed in a laboratory-based testicular environment to promote spermatogenesis into maturity.
Experimental
Infertile Males with Genetic Sterility: Sertoli Cell Only 		Sterile male participants with unexplained or defined genetic infertility of sertoli cell only that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
  • Genetic: Stem 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.
  • Genetic: Genetic Screening
    Serum samples are processed through RNA sequencing to reveal known and novel infertility-related biomarkers and genes.
    Other names:
    • genome mapping
    • genome characterization
  • Genetic: Genetic 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.
  • Genetic: Cell Maturation
    Genetically unmodified and modified cells are placed in a laboratory-based testicular environment to promote spermatogenesis into maturity.
Experimental
Infertile Males with Genetic Sterility: Early/Late Maturation Arrest 		Sterile male participants with unexplained or defined genetic infertility of early to late maturation arrest that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participant will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
  • Genetic: Stem 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.
  • Genetic: Genetic Screening
    Serum samples are processed through RNA sequencing to reveal known and novel infertility-related biomarkers and genes.
    Other names:
    • genome mapping
    • genome characterization
  • Genetic: Genetic 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.
  • Genetic: Cell Maturation
    Genetically unmodified and modified cells are placed in a laboratory-based testicular environment to promote spermatogenesis into maturity.
Experimental
Infertile Men with Acquired Sterility 		Sterile male participants with acquired infertility from chemotherapy, infection, undecended testicles that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
  • Genetic: Stem 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.
  • Genetic: Genetic Screening
    Serum samples are processed through RNA sequencing to reveal known and novel infertility-related biomarkers and genes.
    Other names:
    • genome mapping
    • genome characterization
  • Genetic: Genetic 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.
  • Genetic: Cell Maturation
    Genetically unmodified and modified cells are placed in a laboratory-based testicular environment to promote spermatogenesis into maturity.

Recruiting Locations

The Turek Clinic
San Francisco, California 94108
Contact:
Paul J Turek, MD
4153923200
drpaulturek@gmail.com

More Details

NCT ID
NCT06841861
Status
Recruiting
Sponsor
CellARTs Inc.

Study Contact

Erica S Godart, BS
4244579202
ericagodart@gmail.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center