What this study is
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.
What's being tested
- Stem cell
Intervention · 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
Intervention · GENETIC
Serum samples are processed through RNA sequencing to reveal known and novel infertility-related biomarkers and genes.
- Genetic Reprogramming
Intervention · 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
Intervention · GENETIC
Genetically unmodified and modified cells are placed in a laboratory-based testicular environment to promote spermatogenesis into maturity.
Study details
- Official title
- A Study of Therapeutic Spermatogonial Differentiation for Infertile Men Via Testicular Organoid
- Sponsor
- CellARTs Inc.
- Conditions
- Infertility, Male · Gene Abnormality · Sterility, Male
- Enrolling
- 100 people
- Starts
- 2024-03-28
- Est. completion
- 2027-01-01
- Design
- Open-label, non-randomized, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex MALEHealthy volunteers AcceptedYou may qualify if
- 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.
- 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.
You can't join if
- The lack of diagnosis of fertility or infertility, and lack of testicles.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openThe Turek Clinic
San Francisco, California, United States
- Paul J Turek, MD · Contact4153923200drpaulturek@gmail.com
- Lauren Massey, BSN · Contact4153923200
- Paul J Turek, MD · Principal investigator
Recruiting
Study team
Sponsor
CellARTs Inc.
Study ID SDTO 1
Principal investigator
Paul J Turek, MD
Chief Medical Officer
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.