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

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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.

• 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.

Locations
United States
California
The Turek Clinic
RECRUITING
San Francisco
Contact Information
Primary
Erica S Godart, BS
ericagodart@gmail.com
4244579202
Backup
Constance John, PhD
connie.john@gmail.com
4153054888
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Fertile Males
Fertile male participants (control group) with no known infertility conditions undergoing a vasectomy reversal. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
Experimental: Infertile Males with Genetic Sterility: Sertoli Cell Only
Sterile male participants with unexplained or defined genetic infertility of sertoli cell only that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
Experimental: Infertile Males with Genetic Sterility: Early/Late Maturation Arrest
Sterile male participants with unexplained or defined genetic infertility of early to late maturation arrest that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participant will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
Experimental: Infertile Men with Acquired Sterility
Sterile male participants with acquired infertility from chemotherapy, infection, undecended testicles that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
Related Therapeutic Areas
Sponsors
Leads: CellARTs Inc.
Collaborators: The Turek Clinic, Inc

This content was sourced from clinicaltrials.gov