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临床试验/NCT02025270
NCT02025270已完成1 期

Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年10月15日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
2
主要终点
All Cases Improvement

研究概览

简要总结

In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.

详细描述

Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • All Non obstructive Azoospermic Patients.
  • Azoospermic Patients due to Administration of Chemo/Radiotherapy.

排除标准

  • Patients with Testicular Cancer.
  • Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.

结局指标

主要结局

All Cases Improvement

时间窗: One Year (12-Month)

Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.

次要结局

  • All Cases Fertility Improvement(One Year (12-Month))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sayed Bakry

Associate Professor , Consultant of Separation and Culturing of Stem Cells

Al-Azhar University

研究点 (2)

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