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

Phase 1

• Conditions: Primary Ovarian Insufficiency
• Interventions: Biological: Placebo transplantation; Biological: HUC-MSCs transplantation

• Registration Number: NCT03033277
• Lead Sponsor: Chinese Academy of Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Status Verified: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-24
• Last Update Submitted: 2017-01-24
• Study First Posted: 2017-01-26
• Last Update Posted: 2017-01-26
• Primary Completion: 2017-04
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 320

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo transplantation	Hormone replacement therapy, placebo transplantation.
Experimental group	HUC-MSCs transplantation	Hormone replacement therapy,HUC-MSCs transplantation.

Primary Outcome Measures

Name	Time	Method
Number of mature follicle	Up to 4 months	The number of mature follicles developing was recorded by transvaginal ultrasound scan

Secondary Outcome Measures

Name	Time	Method
Ovarian volume	Up to 4 months	The ovarian volume was recorded by transvaginal ultrasound scan
Anti-Mullerian hormone (AMH) serum level	Up to 4 months	Serum AMH level was evaluated once a month after surgery
Follicle-stimulating hormone (FSH) serum level	Up to 4 months	Serum FSH level was evaluated once a month after surgery
Estradiol (E2) serum level	Up to 4 months	Serum E2 level was evaluated once a month after surgery
Number of antral follicle development	Up to 4 months	The number of antral follicles developing was recorded by transvaginal ultrasound scan
Pregnancy rate	Up to 12 months	The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.

Trial Locations

Locations (1)

Institute of Zoology, Chinese Academy of Sciences.; 🇨🇳 Beijing, Beijing, China