Spermatogonial Differentiation Via Testicular Organoid (SDTO)

CellARTs Inc.

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Genetic: Cell Maturation; Genetic: Genetic Screening; Genetic: Stem cell; Genetic: Genetic Reprogramming

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06841861

SDTO 1

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Fertile Males

Active Comparator group

Description:

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).

Treatment:

Genetic: Genetic Reprogramming

Genetic: Genetic Screening

Genetic: Stem cell

Genetic: Cell Maturation

Infertile Males with Genetic Sterility: Sertoli Cell Only

Experimental group

Description:

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).

Treatment:

Genetic: Genetic Reprogramming

Genetic: Genetic Screening

Genetic: Stem cell

Genetic: Cell Maturation

Infertile Males with Genetic Sterility: Early/Late Maturation Arrest

Experimental group

Description:

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).

Treatment:

Genetic: Genetic Reprogramming

Genetic: Genetic Screening

Genetic: Stem cell

Genetic: Cell Maturation

Infertile Men with Acquired Sterility

Experimental group

Description:

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).

Treatment:

Genetic: Genetic Reprogramming

Genetic: Genetic Screening

Genetic: Stem cell

Genetic: Cell Maturation