Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
1 other identifier
interventional
66
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2019
CompletedFirst Submitted
Initial submission to the registry
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedApril 4, 2022
March 1, 2022
3.7 years
November 25, 2019
March 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Changes in blood flow index in the ovary
9-12 months
Clinical pregnancy rate
9-12 months
Study Arms (2)
UC-MSCs+hormone replacement group
EXPERIMENTALGroup A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group).
hormone replacement group
ACTIVE COMPARATORGroup B was the hormone replacement group (control group).
Interventions
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.
Routine estrogen progesterone replacement periodic therapy
Eligibility Criteria
You may qualify if:
- Those who meet the POF diagnostic criteria and have no spontaneous follicular activity;
- Married, 20 years old ≤ age \< 40 years old;
- The average diameter of each ovary is \> 10 mm;
- Have agreed to sign the informed consent form.
You may not qualify if:
- Female and/or male chromosomal abnormalities;
- Endometriosis, adenomyosis;
- Postoperative ovarian borderline or malignant tumor;
- Uterine dysplasia;
- Associated with female autoimmune disease or other serious internal surgical diseases;
- hormone replacement contraindications;
- In the past 1 year, had received an experimental study of premature ovarian failure in the external hospital;
- Male azoospermia or severe oligozoospermia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Li-jun Dinglead
Study Sites (1)
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guangshu Han, phD
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
November 25, 2019
First Posted
April 4, 2022
Study Start
November 20, 2019
Primary Completion
July 31, 2023
Study Completion
December 1, 2023
Last Updated
April 4, 2022
Record last verified: 2022-03