NCT06841861: SDTO

Spermatogonial Differentiation Via Testicular Organoid

Recruiting now Phase 1, PHASE2 Last updated 24 February 2025

What this trial tests

Phase 1, PHASE2 trial testing Stem cell in Infertility, Male in 100 participants. Currently enrolling.

Timeline

28 March 2024

Primary endpoint
1 December 2026

1 January 2027

Quick facts

Lead sponsor	CellARTs Inc.
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	100
Start date	28 March 2024
Primary completion	1 December 2026
Estimated completion	1 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Stem cell — full drug profile →
• Genetic Screening
• Genetic Reprogramming
• Cell Maturation

Conditions studied

• Infertility, Male — all drugs for Infertility, Male →
• Gene Abnormality — all drugs for Gene Abnormality →
• Sterility, Male — all drugs for Sterility, Male →

Sponsor

CellARTs Inc.

Who can join

Adults 18 to 60, male only, with Infertility, Male or Gene Abnormality. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.