NCT03877471

Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency

Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Stem Cell (MSC)-Like Cells Transplantation in Women With Primary Ovarian Insufficiency (POI)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Chinese Academy of Sciences · Other Government
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Primary Ovarian Insufficiency

Interventions

Type	Name	Description
GENETIC	Cell therapy	Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.

Timeline

• Start date: 2019-04-03
• Primary completion: 2020-07-01
• Completion: 2021-12-31
• First posted: 2019-03-15
• Last updated: 2021-08-05

Locations

1 site across 1 country: China