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NCT06841861 · ClinicalTrials.gov registry record · Phase 1
Spermatogonial Differentiation Via Testicular Organoid
A Phase 1 study of Infertility, Male and Gene Abnormality, sponsored by CellARTs.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06841861: Recruiting Phase 1 study of Infertility, Male and Gene Abnormality, sponsored by CellARTs.
NCT06841861 is a Phase 1 study of Infertility, Male and Gene Abnormality that is actively recruiting participants, run by CellARTs. The registered enrollment target is 100 participants, below the 565-participant average among 8 other Infertility, Male trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06841861, a Phase 1 study of Infertility, Male and Gene Abnormality, is actively recruiting participants, sponsored by CellARTs.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Metric: The presence of viable hSSCs characterized by specific molecular and cellular markers (e.g., GFRα1, PLZF) within a predefined timeframe post-derivation. Assessment Method: Flow cytometry, immunohistochemistry, or RT-PCR to confirm marker expression.
Conditions Studied
Interventions
- GENETIC Stem cell
- GENETIC Genetic Screening
- GENETIC Genetic Reprogramming
- GENETIC Cell Maturation
Study Locations (1)
California
- The Turek Clinic - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 1 |
What NCT06841861 shows while recruiting
NCT06841861 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 565-participant average among 8 other Infertility, Male trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Infertility, Male appearing as the primary indexed condition, and to 4 interventions - of which Stem cell is the first listed.
NCT06841861 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06841861 about?
NCT06841861 is a clinical study titled "Spermatogonial Differentiation Via Testicular Organoid". 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 inclu...
What is the current status of trial NCT06841861?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-03-28. Estimated completion is 2027-01-01.
What conditions does trial NCT06841861 study?
This clinical trial studies the following conditions: Infertility, Male, Gene Abnormality, Sterility, Male.
What interventions are being tested in trial NCT06841861?
The interventions under investigation include: Stem cell (GENETIC), Genetic Screening (GENETIC), Genetic Reprogramming (GENETIC), Cell Maturation (GENETIC).
Who is sponsoring clinical trial NCT06841861?
This trial is sponsored by CellARTs, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06841861 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06841861's enrollment target sits among peer trials
100 4th of 8 higher than 5 of 8 other Infertility, Male trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infertility, Male trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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