Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of participants with return of spermatogenesis
研究概览
简要总结
Spermatogonial stem cell transplantation through ultrasound guided rete testis injection and testicular tissue grafting will be performed for participants who have frozen testicular tissue prior to gonadotoxic therapy. The purpose of this study is to test the safety and feasibility of these transplant technologies and restore fertility for these participants.
详细描述
Azoospermia (no sperm in ejaculated semen) impacts 1% of men in the general population and 15% of infertile men, which translates to 645,000 males between the ages of 20 and 50 (prime reproductive years) in the United States. Spermatogenesis arises from a population of spermatogonial stem cells in the testes that maintain continuous sperm production throughout a man's post-pubertal life. Diseases or medical treatments that compromise the stem cell pool and/or prevent the stem cells from differentiating can cause infertility. Adult men have the option to cryopreserve a semen sample prior to therapy but this is not an option for prepubertal patients who are not yet producing sperm. This study will test the safety and feasibility of two approaches to restore sperm production using previously cryopreserved testicular tissues, which contain spermatogonial stem cells.
The first approach is autologous transplantation of testicular cells, including spermatogonial stem cells, into the testis using ultrasound-guided rete testis injection. The second approach is autologous grafting of intact pieces of testicular tissue under the skin in the scrotum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participant at least in Tanner stage 3
- •Previously cryopreserved and stored testicular tissue/cells (frozen due to an infertility-risking diagnosis or treatment such as chemotherapy or radiation) available for autologous transplantation and grafting
- •Healthy enough to undergo anesthesia
- •Written clearance for the procedure from the patient's hematologist or oncologist to confirm the patient has finished treatment for primary condition and are clear to undergo autologous stem cell transplant
排除标准
- •Participants considered to be high risk for surgical complications
- •Participants with a history of leukemia, lymphoma or testicular cancer or a cancer that likely involved testicles at the time of testicular tissue collection
- •Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
研究组 & 干预措施
Spermatogonial Stem Cell Transplant & Testicular Tissue Graft
Stem cell transplantation Testicular tissue grafting
干预措施: Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting (Procedure)
结局指标
主要结局
Number of participants with return of spermatogenesis
时间窗: 3 months-1year
Rate of participants where sperm was found in semen analysis or testicular tissue analysis
次要结局
- Number of participants with surgical complications of SSC transplantation and testicular tissue grafting(3 months)
- Number of participants with cancer recurrence(5 years)
研究者
Kyle Orwig
Professor
University of Pittsburgh