100 Participants Needed

Stem Cell Therapy for Male Infertility

(SDTO Trial)

LM
PJ
ES
CJ
Overseen ByConstance John, PhD
Age: 18 - 65
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: CellARTs Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Stem Cell Therapy for Male Infertility?

Research shows that stem cell therapy can effectively treat azoospermia (a condition where a man has no sperm in his semen) in animal models, and similar techniques have been used to generate functional sperm cells from patients with certain types of infertility. This suggests potential for stem cell therapy to help treat male infertility in humans.12345

Is stem cell therapy for male infertility safe for humans?

Some studies suggest that stem cell therapies, like reprogramming human somatic cells into male germline stem cells, show high safety in terms of normal chromosome structure and function, but more research is needed to confirm safety in humans.16789

How does the treatment 'Stem Cell Therapy for Male Infertility' differ from other treatments for this condition?

This treatment is unique because it involves reprogramming somatic cells into male germline stem cells, which can then develop into sperm cells, offering a potential solution for men who cannot produce sperm naturally. Unlike traditional fertility treatments that require existing sperm, this approach aims to create sperm from stem cells, providing a novel option for those with severe infertility issues.110111213

What is the purpose of this trial?

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.

Research Team

PJ

Paul J Turek, MD

Principal Investigator

Chief Medical Officer

Eligibility Criteria

This trial is for men experiencing infertility due to genetic abnormalities or failed spermatogenesis. Participants will provide blood, skin tissue, and testicular tissue samples. The study excludes details on specific inclusion and exclusion criteria.

Inclusion Criteria

I am a man aged 18-60 with a diagnosis of no sperm count and have been infertile for over a year.
I am a man aged 18-60 with normal fertility undergoing fertility procedures.

Exclusion Criteria

I have not been diagnosed with fertility issues and I do not have testicles.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants provide blood, skin, and testicular tissue samples for analysis

1-2 weeks
1 visit (in-person)

Ex Vivo Testis Development

Development of the iTestis platform using participant-derived stem cells

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after sample collection and iTestis development

4 weeks

Treatment Details

Interventions

  • Genetic Reprogramming
  • Genetic Screening
  • Stem cell
Trial Overview The trial investigates human sperm production in vitro using an 'iTestis' organ-on-a-chip model. It involves genetic screening of participants, stem cell isolation from tissues provided, and attempts to recreate spermatogenesis outside the body.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Infertile Men with Acquired SterilityExperimental Treatment4 Interventions
Sterile male participants with acquired infertility from chemotherapy, infection, undecended testicles that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
Group II: Infertile Males with Genetic Sterility: Sertoli Cell OnlyExperimental Treatment4 Interventions
Sterile male participants with unexplained or defined genetic infertility of sertoli cell only that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
Group III: Infertile Males with Genetic Sterility: Early/Late Maturation ArrestExperimental Treatment4 Interventions
Sterile male participants with unexplained or defined genetic infertility of early to late maturation arrest that are undergoing sperm mapping or testicular sperm retrieval (TESE) procedures. Participant will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).
Group IV: Fertile MalesActive Control4 Interventions
Fertile male participants (control group) with no known infertility conditions undergoing a vasectomy reversal. Participants will provide human tissue serum (via blood draw), skin (via biopsy), and testicular tissue (via biopsy).

Find a Clinic Near You

Who Is Running the Clinical Trial?

CellARTs Inc.

Lead Sponsor

Trials
1
Recruited
100+

The Turek Clinic, Inc

Collaborator

Trials
1
Recruited
100+

Findings from Research

Human Sertoli cells can be reprogrammed into male germline stem cells (SSCs) by overexpressing specific factors (DAZL, DAZ2, and BOULE), demonstrating a new method for generating male gametes.
The derived SSCs not only showed the ability to proliferate and differentiate into mature sperm cells in vitro but also maintained normal chromosomes, indicating a high safety profile for potential use in treating male infertility.
Direct reprogramming of human Sertoli cells into male germline stem cells with the self-renewal and differentiation potentials via overexpressing DAZL/DAZ2/BOULE genes.Zhang, W., Chen, W., Cui, Y., et al.[2022]
Stem cell transplantation has been shown to effectively treat azoospermia, a major cause of male infertility, based on a systematic review of 18 studies, indicating its potential as a therapeutic option in animal models.
Among different methods, xenotransplantation and the use of umbilical cord mesenchymal stem cells were particularly effective, enhancing the expression of key meiosis-related genes and promoting spermatogenesis, although further research is needed to confirm these findings in humans.
Efficacy of Cellular Therapy for Azoospermia in Animal Models: A Systematic Review and Meta-Analysis.Qiu, J., Ma, H., Pei, Y.[2023]
This study successfully generated functional spermatids from cryptorchid patients, which is crucial for treating male infertility, particularly in azoospermia cases.
The treatment with retinoic acid and stem cell factor significantly enhanced the development of spermatogonial stem cells, leading to haploid spermatids that have the potential for fertilization and embryo development.
Generation of haploid spermatids with fertilization and development capacity from human spermatogonial stem cells of cryptorchid patients.Yang, S., Ping, P., Ma, M., et al.[2020]

References

Direct reprogramming of human Sertoli cells into male germline stem cells with the self-renewal and differentiation potentials via overexpressing DAZL/DAZ2/BOULE genes. [2022]
Efficacy of Cellular Therapy for Azoospermia in Animal Models: A Systematic Review and Meta-Analysis. [2023]
Generation of haploid spermatids with fertilization and development capacity from human spermatogonial stem cells of cryptorchid patients. [2020]
Sterile testis complementation with spermatogonial lines restores fertility to DAZL-deficient rats and maximizes donor germline transmission. [2021]
DDX4-EGFP transgenic rat model for the study of germline development and spermatogenesis. [2018]
The Epigenetic Assessment of Human Spermatogenic Cells Derived from Obstructive Azoospermic Patients in Different Culture Systems. [2021]
Use of human embryonic stem cell-based models for male reproductive toxicity screening. [2014]
Alternative sources of gametes: reality or science fiction? [2022]
Surrogate testes: Allogeneic spermatogonial stem cell transplantation within an encapsulation device may restore male fertility. [2021]
Technology insight: In vitro culture of spermatogonial stem cells and their potential therapeutic uses. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Experimental methods to preserve male fertility and treat male factor infertility. [2018]
Differentiation of bone marrow derived mesenchymal stem cells into male germ-like cells in co-culture with testicular cells. [2020]
Retracted article: In vitro derivation of mammalian germ cells from stem cells and their potential therapeutic application. [2019]
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