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

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.

Study Overview

• Status: Unknown
• Conditions: Primary Ovarian Insufficiency
• Intervention / Treatment: Biological: Placebo transplantation; Biological: HUC-MSCs transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100101
      • Recruiting
      • Institute of Zoology, Chinese Academy of Sciences.
      • Contact: Jianqiao Liu, Doctor; Phone Number: +86-18928916736; Email: ljq88gz@163.com
      • Contact: Yixuan Wu, Doctor; Phone Number: +86-13430202696; Email: 87295667@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Hormone replacement therapy, placebo transplantation.	Biological: Placebo transplantation; Intraovarian injection of placebo through vagina under the guidance of ultrasonic.
Experimental: Experimental group; Hormone replacement therapy,HUC-MSCs transplantation.	Biological: HUC-MSCs transplantation; Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of mature follicle	The number of mature follicles developing was recorded by transvaginal ultrasound scan	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follicle-stimulating hormone (FSH) serum level	Serum FSH level was evaluated once a month after surgery	Up to 4 months
Estradiol (E2) serum level	Serum E2 level was evaluated once a month after surgery	Up to 4 months
Anti-Mullerian hormone (AMH) serum level	Serum AMH level was evaluated once a month after surgery	Up to 4 months
Number of antral follicle development	The number of antral follicles developing was recorded by transvaginal ultrasound scan	Up to 4 months
Ovarian volume	The ovarian volume was recorded by transvaginal ultrasound scan	Up to 4 months
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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: The Third Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Hongmei Wang, Doctor, State Key Laboratory of Stem Cell and Reproductive Biology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: Multi-cited POI Recovery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No