drugset / Trial / NCT02041910

Testicular Injection of Autologous Stem Cells for Treatment of Patients With Azoospermia

NCT02041910

Phase 1/2 Unknown 60 enrolled Hesham Saeed Elshaer
RandomizedSingle-groupOpen-labelTreatment

Summary

Azoospermia is defined as the complete lack of sperm in the ejaculate. In humans, Azoospermia affects about 1% of the male population and may be seen in up to 20% of male infertility situations. In testicular Azoospermia the testes are abnormal, atrophic, or absent, and sperm production severely disturbed to absent. FSH levels tend to be elevated (hypergonadotropic) as the feedback loop is interrupted. The condition is seen in 49-93% of men with Azoospermia. The purpose of this study is to assess the ability of bone marrow derived stem cells to differentiate into germ cells and their role in treatment of testicular Azoospermia

Timeline

Start
2014-01
Primary completion
2015-01
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Rexlemestrocel-L Cell therapy 5 ml Other
Subject Rexlemestrocel-L Cell therapy 3e+06 cells Other
Subject Rexlemestrocel-L Cell therapy 5e+06 cells Other

Indications