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

General Information

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.
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).
Clinical trials phase Phase 1
Start date (estimated) 2019-04-01
End date (estimated) 2021-12-31
Clinical feature
Label primary ovarian insufficiency
Link http://www.ebi.ac.uk/efo/EFO_0004266
Description Absent or premature cessation of ovarian function due to a pathologic process originating within the ovaries.; Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.

Administrative Information

NCT Number NCT03877471
Other study identifiers
Name IOZ ChineseAS POI-2
Source weblink https://clinicaltrials.gov/ct2/show/NCT03877471
Regulatory body approval
Country
Study sites
Public contact
Country
Sponsors Chinese Academy of Sciences
Collaborators

Cell Line

Recruitment

Recruitment Status Recruiting
Estimated number of participants 28
Contact institutions/departments