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Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Stem Cell (MSC)-Like Cells Transplantation in Women With Primary Ovarian Insufficiency (POI)
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of MSC-like cell therapy in women suffering from POI.
The purpose of this work is to explore the safety and preliminary efficacy of human embryonic stem cell derived MSC-like cell transplantation in women with POI. MSC-like cells were injected directly into bilateral ovaries under transvaginal ultrasound. Patients are subjected into 3 groups, with low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells injection for each ovary. The outcomes of patients were followed after the injection every 2 weeks. The investigator mainly follow the safety indexes, and the level of sex hormone and signs of follicle growth will also be monitored. The growing follicles will be stimulated by exogenous hormone, followed by oocyte retrieval and in vitro fertilization (IVF).
Age
0 - 40 years
Sex
FEMALE
Healthy Volunteers
No
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Start Date
April 3, 2019
Primary Completion Date
July 1, 2020
Completion Date
December 31, 2021
Last Updated
August 5, 2021
28
ACTUAL participants
Cell therapy
GENETIC
Lead Sponsor
Chinese Academy of Sciences
Collaborators
NCT06866119
NCT02696889
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