Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
NCT ID: NCT05308342
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
66 participants
INTERVENTIONAL
2019-11-20
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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UC-MSCs+hormone replacement group
Group A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group).
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.
hormone replacement treatment
Routine estrogen progesterone replacement periodic therapy
hormone replacement group
Group B was the hormone replacement group (control group).
hormone replacement treatment
Routine estrogen progesterone replacement periodic therapy
Interventions
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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.
hormone replacement treatment
Routine estrogen progesterone replacement periodic therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
39 Years
FEMALE
No
Sponsors
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Li-jun Ding
OTHER
Responsible Party
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Li-jun Ding
principal investigator
Principal Investigators
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Guangshu Han, phD
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Locations
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Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SZ-POF-2019-4
Identifier Type: -
Identifier Source: org_study_id
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