Spermatogonial Differentiation Via Testicular Organoid

Part of paid clinical trials in San Francisco, California.

Sponsor
CellARTs Inc.
Study ID
NCT06841861
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Gene Abnormality
  • Infertility, Male
  • Sterility, Male

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Stem cell — GENETIC
    Primary cell cultures of tissue cells will be established. Cell cultures will undergo genetic reprogramming to induce the long-term propagation of living cells.
  • Genetic Screening — GENETIC
    Serum samples are processed through RNA sequencing to reveal known and novel infertility-related biomarkers and genes.
  • Genetic Reprogramming — GENETIC
    Genes or gene products will be reinserted into cells to observe how the cells can be changed, or reprogrammed, into embryonic-like cells or into sperm precursor cells.
  • Cell Maturation — GENETIC
    Genetically unmodified and modified cells are placed in a laboratory-based testicular environment to promote spermatogenesis into maturity.

Study Details

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.

Key Dates

Start date
Mar 28, 2024
Status verified
Feb 2025
Primary completion
Dec 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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).

Primary Outcome Measure

Successful derivation of patient-specific human spermatogonial stem cells (hSSCs) from testicular tissue samples. [ Time Frame: From initial sample collection to 24 months post all subject sample collection completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Turek ClinicSan FranciscoCalifornia94108
Paul J Turek, MD
[email protected]
4153923200
Lauren Massey, BSN
4153923200
Paul J Turek, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
The Turek Clinic· San Francisco, CA

Related Studies