drugset / Trial / NCT02043743

Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure

NCT02043743

Phase 1/2 Unknown 60 enrolled El-Rayadh Fertility Centre
NaSingle-groupOpen-labelTreatment

Summary

Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary ovarian insufficiency (this is the most accurate term as some women may still conceive), premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to function adequately in a woman younger than 40 years, in its role either as an endocrine organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism, and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer responding to circulating FSH by producing estrogen and developing fertile eggs) in women younger than 40 years. This condition occurs in approximately 1% of women and it has important physical and psychological consequences/impact in those patients. The purpose of this study is to investigate the role of the transplantation of bone marrow derived stem cells into ovarian tissue for treatment of premature ovarian failure and to assess their ability to differentiate into germ cells.

Timeline

Start
2014-01
Primary completion
2014-04
Completion
2015-01

Drugs

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