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Human Amniotic Epithelial Cells for Asherman's Syndrome

NCT03223454 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-07-21

No results posted yet for this study

Summary

This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome.

Conditions

  • Asherman's Syndrome

Interventions

BIOLOGICAL

biological amnion

Biological amnion is purchased from JiangXi RuiJi BioTechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.

BIOLOGICAL

hAECs

hAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.

Sponsors & Collaborators

  • Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

    collaborator INDUSTRY

  • The Second Affiliated Hospital of Chongqing Medical University

    lead OTHER

Principal Investigators

  • Lina Hu · The Second Affiliated Hospital of Chongqing Medical University

  • Chanyu Zhang · The Second Affiliated Hospital of Chongqing Medical University

  • Fan He · The Second Affiliated Hospital of Chongqing Medical University

  • Jianguo Hu · The Second Affiliated Hospital of Chongqing Medical University

  • Heng Zou · The Second Affiliated Hospital of Chongqing Medical University

  • Huijia Chen · The Second Affiliated Hospital of Chongqing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-09-30
Completion
2021-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03223454 on ClinicalTrials.gov