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NCT Number: NCT06841861

Spermatogonial Differentiation Via Testicular Organoid

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.

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Key information

Conditions

Infertility, Male Gene Abnormality Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Sterility, Male Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Turek Clinic

San Francisco, California, 94108, United States

Location status: Recruiting

Location contact

Lauren Massey, BSN

CONTACT

4153923200

Paul J Turek, MD

CONTACT

[email protected]

4153923200

Paul J Turek, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stem cell

Genetic

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 Screening

Genetic

Serum samples are processed through RNA sequencing to reveal known and novel infertility-related biomarkers and genes.

Other names: genome mapping, genome characterization

Genetic Reprogramming

Genetic

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.

Cell Maturation

Genetic

Genetically unmodified and modified cells are placed in a laboratory-based testicular environment to promote spermatogenesis into maturity.

Primary outcomes

  1. Successful derivation of patient-specific human spermatogonial stem cells (hSSCs) from testicular tissue samples.

    Time frame: From initial sample collection to 24 months post all subject sample collection completion

    Metric: The presence of viable hSSCs characterized by specific molecular and cellular markers (e.g., GFRα1, PLZF) within a predefined timeframe post-derivation.

    Assessment Method: Flow cytometry, immunohistochemistry, or RT-PCR to confirm marker expression.

Other outcomes

  1. Development and functional validation of an ex vivo testis organ-on-a-chip ('iTestis') platform for the cultivation and maintenance of isolated spermatogonial stem cells (hSSCs)

    Time frame: From the date of the first successful derivation of patient-specific hSSCs until an ex vivo testis platform is developed and can functionally cultivate and maintain the isolated spermatogonial stem cells (hSSCs), assessed for up to 24 months.

    Metric: Successful development of a biomimetic iTestis capable of maintaining hSSCs in a viable and undifferentiated state over a predefined culture period.

    Assessment Method:

    Viability: Measured by live/dead assays or metabolic activity (e.g., MTT or ATP assays).

    Stemness: Expression of hSSC markers (e.g., GFRα1, PLZF) using immunofluorescence or qRT-PCR.

  2. Promotion of human spermatogenesis in vitro ('iSperm') using hSSCs and hiPSCs within the iTestis platform.

    Time frame: From the date of the initial development of the ex vivo testis platform until the promotion of human spermatogenesis using hSSCs and hiPSCs is achieved within the iTestis platform, assessed for up to 24 months.

    Metric: Generation of haploid spermatogenic cells (e.g., spermatocytes, spermatids, or sperm-like cells) from hSSCs and/or hiPSCs cultured within the iTestis platform.

    Assessment Method:

    Flow cytometry or fluorescence-activated cell sorting (FACS) to confirm haploid cell production (e.g., 1N DNA content).

    Gene and protein expression analysis of spermatogenic markers (e.g., SCP3, acrosin, protamine 1) using RT-PCR and immunofluorescence.

  3. Successful derivation of patient-specific induced pluripotent stem cells (hiPSCs) from skin samples.

    Time frame: From initial sample collection to 24 months post all subject sample collection completion.

    Metric: Generation of hiPSCs that exhibit hallmark pluripotency characteristics from participant skin fibroblasts.

    Assessment Method:

    Morphological Analysis: Observation of colony morphology consistent with hiPSCs.

    Molecular and Functional Validation:

    Expression of key pluripotency markers (e.g., OCT4, SOX2, NANOG) verified by immunofluorescence, qRT-PCR, or flow cytometry.

    Functional pluripotency confirmed via in vitro differentiation into the three germ layers (endoderm, mesoderm, ectoderm).

Study contacts

Contact information is provided by the study sponsor or research team.

Constance John, PhD

CONTACT

[email protected]

4153054888

Erica S Godart, BS

CONTACT

[email protected]

4244579202

Sponsors and collaborators

Lead sponsor

CellARTs Inc.

Industry

Collaborators

  • The Turek Clinic, Inc

Registry information

Official study title

A Study of Therapeutic Spermatogonial Differentiation for Infertile Men Via Testicular Organoid

Acronym: SDTO

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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