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Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04232592
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Information provided by (Responsible Party):
Qi Zhou, Chinese Academy of Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Biological: Inject a solution of stem cell preparation Biological: Inject stem cells Phase 1

Detailed Description:
In this study, a single-center, controlled, open-label design was used for a dose escalation study.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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Stem cell preparation solution injection group
The solution of stem cells preparation will be injected.
Biological: Inject a solution of stem cell preparation
The control group was injected with a solution of stem cell preparation

Experimental: Injected stem cell group
The stem cells will injected.
Biological: Inject stem cells
Three dose groups were designed: low dose group, medium dose group and high dose group.




Primary Outcome Measures :
  1. Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells [ Time Frame: Within 48 weeks after surgery ]
    Adverse events (AE), severe adverse events (SAE), and treatment-related adverse events (TEAE) occurred within 48 weeks after surgery.


Secondary Outcome Measures :
  1. Normal recovery rate of endometrial thickness [ Time Frame: 12 months ]
    Normal recovery rate of endometrial thickness at 1 and 2 months after surgery will be measured (effective rate = endometrium > 6mm after surgery/all participants ×100%).

  2. recurrence rate of intrauterine adhesions [ Time Frame: 12 months ]
    Recurrence rate of intrauterine adhesions (defined as patients with recurrence of intrauterine adhesions reviewed by hysteroscopy at 1 month/total patients ×100%) will be measured.

  3. Intrauterine adhesions score [ Time Frame: 12 months ]
    Intrauterine adhesions score will be measured according to the American Fertility Society in 1988 diagnostic criteria for intrauterine adhesions.The scores range from 1 to 12. Higher scores mean a worse outcome.

  4. The endometrial biopsies for CD31 [ Time Frame: 12 months ]
    Immunohistochemical results of CD31 during the two endometrial biopsies will be measured.

  5. Menstrual volume change [ Time Frame: 12 months ]
    Menstrual volume change will be assessed according to menstrual blood loss chart.

  6. Clinical pregnancy rate [ Time Frame: 12 months ]
    Clinical pregnancy rate, abortion rate, live birth rate, and sustained pregnancy rate (defined as live pregnancy over 12 weeks) will be assessed.

  7. The endometrial biopsies for estrogen [ Time Frame: 12 months ]
    Estrogen receptor levels during the two endometrial biopsies will be measured.

  8. The endometrial biopsies for Ki67 [ Time Frame: 12 months ]
    Ki67 expression levels during the two endometrial biopsies will be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Criteria:

Inclusion Criteria:

  • 18 ≤ age ≤38, female;
  • According to the 1988 American Fertility Society (AFS) diagnostic criteria, patients with uterine adhesions diagnosed with full civil capacity and with a score of ≥5 were enrolled in the study;
  • The patient had one or more of the following clinical symptoms: reduced menstruation or amenorrhea, periodic abdominal pain, secondary infertility, recurrent abortion, premature delivery and other adverse pregnancy outcomes;
  • The uterus was smaller than 8 weeks gestation and the uterine cavity depth was less than 12 cm;
  • The second to fifth day of menstruation FSH <10mIU/mL, AMH >1.2ng/mL, AFC>6;
  • Understand and sign informed consent voluntarily.

Exclusion Criteria:

  • Patients with acute pelvic inflammation or endometriosis;
  • Having or having a history of malignancy;
  • Thrombus, lupus erythematosus and other hormone use contraindications; Allergic to albumin products;
  • Patients with uterine malformation, adenomyosis, submucosal uterine fibroids,and uterine fibroids of any site >5cm;
  • Patients who were using anticoagulants or who had not recovered normal platelet function 10 days after discontinuation of antiplatelet drugs;
  • Previous history of abnormal coagulation function or abnormality before cell transplantation;
  • Always has a history of abnormal bleeding (such as abnormal bleeding during tooth extraction), or their immediate family members have hemorrhagic disease,such as hemophilia, bleeding symptoms (e.g., hematemesis, black, serious or recurrent nasal bleeding, coughing up blood, obvious hematuria, gastrointestinal bleeding, or intracranial hemorrhage), or suspected of vascular malformation such as aneurysm by researchers determine influence cell implant operation;
  • Alcohol or drug addiction;
  • Participated in other interventional clinical trials within 90 days before the informed consent was signed or before the cell transplantation;
  • Had used glucocorticoids or immunosuppressive drugs within 12 weeks before signing the informed consent;
  • Had used antipsychotic drugs, such as antidepressants and anti-manic drugs, within 12 weeks before signing the informed consent;
  • Severe heart failure within 24 weeks before the informed consent;
  • Glomerular filtration rate (eGFR) <90ml/min;
  • ALT>3 times normal upper limit;
  • Concomitant with other serious systemic diseases, such as pulmonary heart disease, severe chronic obstructive pulmonary disease (COPD), etc;
  • Patients with severe clinical infection should receive antibiotics within 1 week before signing the informed consent;
  • Active infectious diseases, including but not limited to positive human immunodeficiency virus and syphilis antibody;
  • The researchers considered poor compliance;
  • Other conditions not suitable for participation in this clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232592


Contacts
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Contact: Liu Wang, Doctor +86-01064807858 wangliu@ioz.ac.cn
Contact: Jie Hao, Doctor +86-01062558737 haojie@ioz.ac.cn

Sponsors and Collaborators
Qi Zhou
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Investigators
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Principal Investigator: Qi Zhou, Doctor Institute of zoology, Chinese Academy of Sciences
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Responsible Party: Qi Zhou, Director of Institute of zoology, chinese academy of sciences, and vice president of medical school, University of chinese academy of sciences, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT04232592    
Other Study ID Numbers: Chinese ASZQ-005
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes