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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 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.

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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.

Conditions Studied

Infertility, Male Gene Abnormality Sterility, Male

Interventions

  • GENETIC Stem cell
  • GENETIC Genetic Screening
  • GENETIC Genetic Reprogramming
  • GENETIC Cell Maturation

Study Locations (1)

California

  • The Turek Clinic - San Francisco

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-03-28
Est. Completion 2027-01-01
Phase Phase 1

Sponsor

CellARTs

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06841861

The ClinicalTrials.gov registry entry for NCT06841861 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 565-participant average among 8 other Infertility, Male trials with a reported enrollment target (82% lower). The listed sponsor is CellARTs, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.