Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
MALE
Healthy Volunteers
ID06841861

A Study of Therapeutic Spermatogonial Differentiation for Infertile Men Via Testicular Organoid

Led by CellARTs Inc. · Updated on 2025-02-24

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

C

CellARTs Inc.

Lead Sponsor

T

The Turek Clinic, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the possibility of producing human sperm in the laboratory by maintaining an adult testicular environment outside the body. The study aims to identify genetic markers linked to male sterility and failed sperm production, and to develop a testicular "organ-on-a-chip" system called "iTestis" to support stem cell growth. This system will be used to see if human sperm production can be recreated in vitro using stem cells nurtured in the iTestis model. Participants are divided into groups including fertile males undergoing vasectomy reversal and infertile males with different types of genetic or acquired infertility. Participants will provide blood samples, skin biopsies, and testicular tissue obtained through routine clinical procedures like fine needle aspiration or testicular sperm extraction. The study uses genetic screening, reprogramming, and cell maturation techniques to cultivate stem cells and promote sperm development in the lab. Throughout the study, participants will provide various tissue samples for analysis and stem cell cultivation. Researchers will monitor the successful derivation of patient-specific spermatogonial stem cells from testicular tissue over a period extending up to 24 months after sample collection. The trial includes serum analysis, skin and testicular biopsies, and genetic tests to understand infertility causes and support sperm production research.

CONDITIONS

Brief Title

Spermatogonial Differentiation Via Testicular Organoid

Who Can Participate

Age: 18Years - 60Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male sex between 18 and 60 years old
  • Evidence of fertility or normal spermatogenesis for fertile control group
  • Undergoing clinical fertility or infertility procedures
  • Males with infertility lasting more than 1 year for infertile groups
  • Diagnosis of azoospermia under clinical evaluation for infertile groups
Not Eligible

You will not qualify if you...

  • No diagnosis of fertility or infertility
  • Lack of testicles

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Genetic Intervention

Duration - Up to 24 months post sample collection completion

Participants provide tissue and blood samples for genetic screening and undergo procedures involving genetic reprogramming and cell maturation in a laboratory setting.

1 initial sample collection visit (in-person)

Trial Site Locations

Total: 1 location

1

The Turek Clinic

San Francisco, California, United States, 94108

Actively Recruiting

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Research Team

E

Erica S Godart, BS

C

Constance John, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

4

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Published Research Related To This Trial

Fate of iPSCs derived from azoospermic and fertile men following xenotransplantation to murine seminiferous tubules.

Cyril Ramathal, Jens Durruthy-Durruthy, Meena Sukhwani...

https://pubmed.ncbi.nlm.nih.gov/24794432

Rapid and efficient conversion of integration-free human induced pluripotent stem cells to GMP-grade culture conditions.

Jens Durruthy-Durruthy, Sharon F Briggs, Jason Awe...

https://pubmed.ncbi.nlm.nih.gov/24718618