Spermatogonial Differentiation Via Testicular Organoid

Last updated: February 20, 2025
Sponsor: CellARTs Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Infertility

Treatment

Genetic Reprogramming

Genetic Screening

Stem cell

Clinical Study ID

NCT06841861
SDTO 1
  • Ages 18-60
  • Male
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 orinfertility 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 orinfertility procedures performed for clinical purposes.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Genetic Reprogramming
Phase: 1/2
Study Start date:
March 28, 2024
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • The Turek Clinic

    San Francisco, California 94108
    United States

    Active - Recruiting

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