Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells
NCT ID: NCT02204358
Last Updated: 2014-07-30
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
PHASE4
30 participants
INTERVENTIONAL
2012-01-31
2015-12-31
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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autologous bone marrow stem cells
Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.
autologous bone marrow stem cells
Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.
If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.
Interventions
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autologous bone marrow stem cells
Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.
If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hysteroscopy examination confirmed intrauterine adhesions or endometrial dysplasia
* Monitoring of endometrial cycle
* Sign a consent form
* Follow the test plan and follow-up process
Exclusion Criteria
* Congenital uterine malformations
* Severe endometriosis
* Severe adenomyosis
* Contraindications to pregnancy
* Contraindications to bone marrow collection
* Contraindications to hormone replacement therapy
* Medical history of pelvic tumors or receiving pelvic radiotherapy
* Unable to adhere to the hospital examination and follow-up, or carrying on other treatment during follow-up period
20 Years
40 Years
FEMALE
Yes
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
MD,PhD
Principal Investigators
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Yali HU, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Vice-president of 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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Central Contacts
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Facility Contacts
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Other Identifiers
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2012022
Identifier Type: -
Identifier Source: org_study_id
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