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

Primary Ovarian Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03033277
• Other study ID #: Multi-cited POI Recovery
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 10, 2017
• Last updated: January 24, 2017
• Start date: February 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2017
• Source: Chinese Academy of Sciences
• Contact: Long Yan, Doctor
• Phone: +86-15650717331
• Email: yanlong[@]ioz.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: July 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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;

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Turner Syndrome

Intervention

Biological:
• Placebo transplantation
Intraovarian injection of placebo through vagina under the guidance of ultrasonic.
• HUC-MSCs transplantation
Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.

Locations

Country	Name	City	State
China	Institute of Zoology, Chinese Academy of Sciences.	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	The Third Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

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