NCT06841861 Spermatogonial Differentiation Via Testicular Organoid
| NCT ID | NCT06841861 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CellARTs Inc. |
| Condition | Infertility, Male |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-28 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-03-28 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Paul J Turek, MD
PRINCIPAL INVESTIGATOR
Chief Medical Officer
Frequently Asked Questions
Who can join the NCT06841861 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 60 Years, studying Infertility, Male. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06841861 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06841861 currently recruiting?
Yes, NCT06841861 is actively recruiting participants. Contact the research team at ericagodart@gmail.com for enrollment information.
Where is the NCT06841861 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06841861 clinical trial?
NCT06841861 is sponsored by CellARTs Inc.. The principal investigator is Paul J Turek, MD at Chief Medical Officer. The trial plans to enroll 100 participants.