Status:
UNKNOWN
Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency
Lead Sponsor:
Chinese Academy of Sciences
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
National Natural Science Foundation of China
Conditions:
Primary Ovarian Insufficiency
Eligibility:
FEMALE
Up to 40 years
Phase:
PHASE1
Brief 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...
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 i...
Eligibility Criteria
Inclusion
- Under 40 years of age;
- Have established regular menstrual cycle, oligomenorrhea / amenorrhea ≥ 4 months;
- FSH (Follicle-Stimulating Hormone) \> 25 IU/mL;
- Bilateral ovaries are visible by ultrasound;
- Have fertility requirement, husband has sperms;
- Willing to sign the Informed Consent Form.
Exclusion
- Primary amenorrhea;
- History of serious drug allergy or allergic constitution;
- Thrombophlebitis and thromboembolia, past and present;
- Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease
- Autoimmune disease, history of severe familial genetic disease, etc.
- Anatomical abnormality of reproductive system;
- Contraindications for pregnancy;
- Spouse azoospermia;
- HIV+, hepatitis B, C;
- Thyroid dysfunction;
- History of previous malignant or ovarian tumors, history of ovarian therapy;
- Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
- During pregnancy or lactation;
- Alcohol or other substance abuse;
- Mental disease, communicate obstruction;
- Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
- Attending doctor consider inappropriate to take part in.
Key Trial Info
Start Date :
April 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03877471
Start Date
April 3 2019
End Date
December 31 2021
Last Update
August 5 2021
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052