Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)

Chinese Academy of Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Primary Ovarian Insufficiency

Treatments: Biological: Placebo transplantation; Biological: HUC-MSCs transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03033277

Multi-cited POI Recovery

Details and patient eligibility

About

There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.

Enrollment: 320 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with primary ovarian insufficiency;
2. Women between 20 and 40 years;
3. Have fertility requirements, husband has sperm;
4. Willing to sign the Informed Consent Form.

Exclusion criteria

1. Primary amenorrhea;
2. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
3. Thyroid dysfunction;
4. Severe endometriosis;
5. Contraindications for pregnancy;
6. Prior personal history of ovarian cancer;
7. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
8. History of serious drug allergy or allergic constitution;
9. Autoimmune disease, history of severe familial genetic disease;
10. HIV+, hepatitis B, C;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Hormone replacement therapy, placebo transplantation.

Treatment:

Biological: Placebo transplantation

Experimental group

Experimental group

Description:

Hormone replacement therapy,HUC-MSCs transplantation.

Treatment:

Biological: HUC-MSCs transplantation