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

March 25, 2022 updated by: Li-jun Ding
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UC-MSCs+hormone replacement group
Group A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group).
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
Other Names:
  • HRT
Active Comparator: hormone replacement group
Group B was the hormone replacement group (control group).
Drug: hormone replacement treatment
Routine estrogen progesterone replacement periodic therapy
Other Names:
  • HRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follicular development rate
Time Frame: 9-12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood flow index in the ovary
Time Frame: 9-12 months
Ovarian artery blood flow spectrum PI; RI; S/D (L; R)
9-12 months
Clinical pregnancy rate
Time Frame: 9-12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li-jun Ding

Investigators

  • Principal Investigator: Guangshu Han, phD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2019

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZ-POF-2019-4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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