RECRUITING

Spermatogonial Differentiation Via Testicular Organoid

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-28
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06841861

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male sex of reproductive age (between 18 - 60 years old).
  2. * Evidence of fertility or normal spermatogenesis.
  3. * Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Erica S Godart, BS
CONTACT
4244579202
ericagodart@gmail.com
Constance John, PhD
CONTACT
4153054888
connie.john@gmail.com

Principal Investigator

Paul J Turek, MD
PRINCIPAL_INVESTIGATOR
Chief Medical Officer

Study Locations (Sites)

The Turek Clinic
San Francisco, California, 94108
United States

Collaborators and Investigators

Sponsor: CellARTs Inc.

  • Paul J Turek, MD, PRINCIPAL_INVESTIGATOR, Chief Medical Officer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-28
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2024-03-28
Study Completion Date2027-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Infertility, Male
  • Gene Abnormality
  • Sterility, Male