Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Premature Ovarian Insufficiency Clinical Trial

Official title:

Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05308342
• Other study ID #: SZ-POF-2019-4
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2022
• Source: Nanjing University
• Contact: Haixiang Sun, phD
• Phone: +862583107188
• Email: stevensunz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was a single-center, randomized, controlled prospective study. Those who had premature ovarian failure and who had fertility requirements were enrolled in the study. To determine the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of patients with POI.

Description:

According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells (test group). Group B was the hormone replacement group (control group).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 1, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Those who meet the POF diagnostic criteria and have no spontaneous follicular activity;

2. Married, 20 years old = age < 40 years old;

3. The average diameter of each ovary is > 10 mm;

4. Have agreed to sign the informed consent form.

Exclusion Criteria:

1. Female and/or male chromosomal abnormalities;

2. Endometriosis, adenomyosis;

3. Postoperative ovarian borderline or malignant tumor;

4. Uterine dysplasia;

5. Associated with female autoimmune disease or other serious internal surgical diseases;

6. hormone replacement contraindications;

7. In the past 1 year, had received an experimental study of premature ovarian failure in the external hospital;

8. Male azoospermia or severe oligozoospermia.

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

Intervention

Procedure:
• transplantation of human UC-MSCs into ovaries of POI patients
UC-MSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the China Food and Drug Administration) are injected into the ovary of patients under transvaginal ultrasonographic (TVUS)-guidance. A total number of 10×106 cells, 5×106 for unilateral ovarian injection) is immediately preserved and transferred for direct injection. After vaginal sterilization, TVUS-guided transplantation is performed by two senior-level medical physicians, using a SIEMENS ACUSON ANTANES premium edition system (SIEMENS AG Healthcare Sector, Erlangen, Germany), equipped with a 6-10 MHz probe. The UC-MSC solution is injected into the ovary by using 21-G PTC needles (Hakko Medical Co, Japan) under TVUS guidance.

Drug:
• hormone replacement treatment
Routine estrogen progesterone replacement periodic therapy

Locations

Country	Name	City	State
China	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Li-jun Ding

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follicular development rate	Follicular development and hormonal examination were performed 1 week before treatment and at 1, 2, and 3 weeks after treatment to evaluate the development of follicles. If there is no follicular development in the third week, stop the drug after 1 week, and contact the next treatment time after menstruation. During the follow-up period to half a year after the end of the last treatment, the follicular development activity rate was observed.	9-12 months
Secondary	Changes in blood flow index in the ovary	Ovarian artery blood flow spectrum PI; RI; S/D (L; R)	9-12 months
Secondary	Clinical pregnancy rate	Clinical pregnancy was defined as diagnosed by increasing serum concentration of beta-HCG 14 days after embryo transfer, and the subsequent demonstration of an intrauterine gestational sac by ultrasonography on 30 days after embryo transfer	9-12 months