Creating human sperm in a lab using testicular organoids
A Study of Therapeutic Spermatogonial Differentiation for Infertile Men Via Testicular Organoid
This study is testing if scientists can create human sperm in a lab using special tissue samples from men to help understand and treat male infertility.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | CellARTs Inc. Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06841861 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the potential for producing human sperm in vitro by maintaining a laboratory-cultured adult testicular environment. Researchers will analyze genetic factors linked to male infertility and failed sperm production by comparing genomic profiles of fertile and infertile males. The study involves constructing an 'organ-on-a-chip' model called iTestis to support the cultivation of spermatogonial stem cells and assess whether human spermatogenesis can be recreated outside the body. Participants will provide testicular and skin tissue samples for this innovative approach.
Who should consider this trial
Good fit: Ideal candidates include males aged 18-60 with either evidence of fertility or a diagnosis of infertility, specifically those with azoospermia.
Not a fit: Patients without a diagnosis of fertility or infertility, or those lacking testicles, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatments for male infertility and improve sperm production in men with genetic abnormalities.
How similar studies have performed: While the approach of using organ-on-a-chip technology is innovative, similar studies exploring spermatogenesis in vitro have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
San Francisco, California
- The Turek Clinic — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Paul J Turek, MD — Chief Medical Officer
- Study coordinator: Erica S Godart, BS
- Email: ericagodart@gmail.com
- Phone: 4244579202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.