The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
NCT ID: NCT03592849
Last Updated: 2022-09-28
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-09-10
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UC-MSCs therapy
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring
UC-MSCs therapy
After history taking, physical examination, ultrasound examination and hysteroscopy examination，infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory.
Interventions
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UC-MSCs therapy
After history taking, physical examination, ultrasound examination and hysteroscopy examination，infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective
3. 20-42 years old
4. Normal ovarian function or with frozen embryos
5. Willing to actively cooperate with postoperative follow-up
Exclusion Criteria
2. With other uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
3. Systemic diseases: hypertension, diabetes, and so on
4. Contraindications to pregnancy
5. Contraindications to hormone replacement therapy
6. Medical history of pelvic tumors or receiving pelvic radiotherapy
7. Involved in other clinical studies
8. Unable to adhere to the follow-up
20 Years
42 Years
FEMALE
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Yali Hu
Professor，Chief Physician of Obstetrics and Gynecology
Principal Investigators
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Yali Hu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Locations
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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SC201700101
Identifier Type: -
Identifier Source: org_study_id
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