Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
MALE
Healthy Volunteers
NCT06841861

Spermatogonial Differentiation Via Testicular Organoid

Led by CellARTs Inc. · Updated on 2025-02-24

100

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

C

CellARTs Inc.

Lead Sponsor

T

The Turek Clinic, Inc

Collaborating Sponsor

AI-Summary

What this Trial 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: 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

Official Title

Spermatogonial Differentiation Via Testicular Organoid

Who Can Participate

Age: 18Years - 60Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male sex between 18 and 60 years old
  • Evidence of fertility or normal spermatogenesis for fertile control group
  • Undergoing planned fertility or infertility procedures for clinical purposes
  • For infertile groups: infertility lasting more than 1 year
  • Diagnosis of azoospermia based on clinical evaluation for infertile groups
Not Eligible

You will not qualify if you...

  • Lack of diagnosis of fertility or infertility
  • Absence of testicles

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Turek Clinic

San Francisco, California, United States, 94108

Actively Recruiting

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Research Team

E

Erica S Godart, BS

CONTACT

C

Constance John, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

4

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Spermatogonial Differentiation Via Testicular Organoid | DecenTrialz