A Study of Therapeutic Spermatogonial Differentiation for Infertile Men Via Testicular Organoid
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Successful derivation of patient-specific human spermatogonial stem cells (hSSCs) from testicular tissue samples.
研究概览
简要总结
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:
- Identifying genomic markers associated with sterility and failed spermatogenesis.
- Developing an ex vivo (outside the body) testis "organ-on-a-chip" ("iTestis") to support stem cell cultivation.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Group 1 (Fertile Control)
- •Male sex of reproductive age (between 18 - 60 years old).
- •Evidence of fertility or normal spermatogenesis.
- •Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.
- •Inclusion Criteria: Group 2 and 3 (Infertile)
- •Male sex of reproductive age (between 18 - 60 years old).
- •Males with evidence of >1 year of infertility.
- •Posesses diagnosis of azoospermia is on clinical evaluation.
- •Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.
排除标准
- •The lack of diagnosis of fertility or infertility, and lack of testicles.
结局指标
主要结局
Successful derivation of patient-specific human spermatogonial stem cells (hSSCs) from testicular tissue samples.
时间窗: From initial sample collection to 24 months post all subject sample collection completion
Metric: The presence of viable hSSCs characterized by specific molecular and cellular markers (e.g., GFRα1, PLZF) within a predefined timeframe post-derivation. Assessment Method: Flow cytometry, immunohistochemistry, or RT-PCR to confirm marker expression.
次要结局
未报告次要终点