Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells
NCT ID: NCT02313415
Last Updated: 2017-10-24
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
26 participants
INTERVENTIONAL
2014-11-28
2017-08-31
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 recurrent intrauterine adhesions
UC-MSCs therapy
Before considering whether patients meet the inclusion criteria, they are diagnosed as intrauterine adhesions with at least one unsuccessful hysteroscopic surgery. And after that there will be history taking, physical examination, ultrasound examination and hysteroscopy examination. If they agree to participate, they will receive separation of adhesions by hysteroscopy surgery and endometrial biopsies, then a collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity. The procedure was performed after taking 6 mg/day × 10 days Progynova, continuous administration of the same dosage Progynova for 30 days and 60mg of progesterone were injected on the 30th day post-operation. Postoperative observation including ultrasound examination once a month for 3 times and hysteroscopy after 3 months. The doctor will select an appropriate time for pregnancy and follow-up including requiring patients to do some unscheduled visits.
Interventions
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UC-MSCs therapy
Before considering whether patients meet the inclusion criteria, they are diagnosed as intrauterine adhesions with at least one unsuccessful hysteroscopic surgery. And after that there will be history taking, physical examination, ultrasound examination and hysteroscopy examination. If they agree to participate, they will receive separation of adhesions by hysteroscopy surgery and endometrial biopsies, then a collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity. The procedure was performed after taking 6 mg/day × 10 days Progynova, continuous administration of the same dosage Progynova for 30 days and 60mg of progesterone were injected on the 30th day post-operation. Postoperative observation including ultrasound examination once a month for 3 times and hysteroscopy after 3 months. The doctor will select an appropriate time for pregnancy and follow-up including requiring patients to do some unscheduled visits.
Eligibility Criteria
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Inclusion Criteria
* Hysteroscopy examination confirmed intrauterine adhesions
* Sign a consent form
* Follow the test plan and follow-up process
Exclusion Criteria
* Chromosome karyotype abnormalities
* Congenital uterine malformations
* Severe adenomyosis
* Contraindications to estradiol treatment
* Medical history of pelvic tumors or receiving pelvic radiotherapy
20 Years
45 Years
FEMALE
No
Sponsors
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Institute of genetic development, Chinese Academy of Sciences
UNKNOWN
Institute of Zoology, Chinese Academy of Sciences
OTHER_GOV
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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References
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Cao Y, Sun H, Zhu H, Zhu X, Tang X, Yan G, Wang J, Bai D, Wang J, Wang L, Zhou Q, Wang H, Dai C, Ding L, Xu B, Zhou Y, Hao J, Dai J, Hu Y. Allogeneic cell therapy using umbilical cord MSCs on collagen scaffolds for patients with recurrent uterine adhesion: a phase I clinical trial. Stem Cell Res Ther. 2018 Jul 11;9(1):192. doi: 10.1186/s13287-018-0904-3.
Other Identifiers
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20141206
Identifier Type: -
Identifier Source: org_study_id