Stem Cell Therapy for Male Infertility
(SDTO Trial)
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Sample Collection
Participants provide blood, skin, and testicular tissue samples for analysis
Ex Vivo Testis Development
Development of the iTestis platform using participant-derived stem cells
Follow-up
Participants are monitored for safety and effectiveness after sample collection and iTestis development
Treatment Details
Interventions
- Genetic Reprogramming
- Genetic Screening
- Stem cell
Find a Clinic Near You
Who Is Running the Clinical Trial?
CellARTs Inc.
Lead Sponsor
The Turek Clinic, Inc
Collaborator