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RecruitingAccepts healthy volunteersPhase 1/Phase 2

Spermatogonial Differentiation Via Testicular Organoid

CellARTs Inc. · with The Turek Clinic, Inc · NCT06841861

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · Men only
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
100
US sites recruiting
1
Study start
March 28, 2024
Record last updated
February 24, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

  • Identifying genomic markers associated with sterility and failed spermatogenesis.
  • Developing an ex vivo (outside the body) testis "organ-on-a-chip" ("iTestis") to support stem cell cultivation.
  • 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.

Being studied: Stem cell; Genetic Screening; Genetic Reprogramming; Cell Maturation

Conditions: Infertility, Male; Gene Abnormality; Sterility, Male

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • The Turek Clinic

    San Francisco, CA 94108

    Site contact: Paul J Turek, MD · 4153923200 · drpaulturek@gmail.com

Study contacts (from the official record)

  • Erica S Godart, BS · 4244579202 · ericagodart@gmail.com
  • Constance John, PhD · 4153054888 · connie.john@gmail.com
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Spermatogonial Differentiation Via Testicular Organoid (NCT06841861) | Bored Studies