Sponsor study identifier
interventional
32
0 countries
N/A
Study Start
January 2020
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Primary Completion
January 2022
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Study Completion
January 2022
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To observe the clinical safety of intrauterine injection of human embryonic stem cell derived mesenchymal cells in the treatment of moderate and severe intrauterine adhesion, and to preliminarily explore its clinical effectiveness in promoting endometrial regeneration and repair.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 27, 2019
Actual (reported)January 2020
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January 18, 2020
Actual (reported)January 2022
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January 2022
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Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells
Adverse events (AE), severe adverse events (SAE), and treatment-related adverse events (TEAE) occurred within 48 weeks after surgery.
Within 48 weeks after surgery
Normal recovery rate of endometrial thickness
12 months
recurrence rate of intrauterine adhesions
12 months
Intrauterine adhesions score
12 months
The endometrial biopsies for CD31
12 months
Menstrual volume change
12 months
The solution of stem cells preparation will be injected.
The stem cells will injected.
The control group was injected with a solution of stem cell preparation
Three dose groups were designed: low dose group, medium dose group and high dose group.
Qi Zhou, Doctor
Institute of Zoology, Chinese Academy of Sciences
First Submitted
December 27, 2019
First Posted
January 18, 2020
Study Start
January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis
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January 2022
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Study Completion
January 2022
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Last Updated
January 18, 2020
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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