- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04232592
Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions
January 15, 2020 updated by: Qi Zhou
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liu Wang, Doctor
- Phone Number: +86-01064807858
- Email: wangliu@ioz.ac.cn
Study Contact Backup
- Name: Jie Hao, Doctor
- Phone Number: +86-01062558737
- Email: haojie@ioz.ac.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Stem cell preparation solution injection group
The solution of stem cells preparation will be injected.
|
The control group was injected with a solution of stem cell preparation
|
EXPERIMENTAL: Injected stem cell group
The stem cells will injected.
|
Three dose groups were designed: low dose group, medium dose group and high dose group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Within 48 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%).
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
The endometrial biopsies for CD31
Time Frame: 12 months
|
Immunohistochemical results of CD31 during the two endometrial biopsies will be measured.
|
12 months
|
Menstrual volume change
Time Frame: 12 months
|
Menstrual volume change will be assessed according to menstrual blood loss chart.
|
12 months
|
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.
|
12 months
|
The endometrial biopsies for estrogen
Time Frame: 12 months
|
Estrogen receptor levels during the two endometrial biopsies will be measured.
|
12 months
|
The endometrial biopsies for Ki67
Time Frame: 12 months
|
Ki67 expression levels during the two endometrial biopsies will be measured.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Qi Zhou, Doctor, Institute of zoology, Chinese Academy of Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 1, 2020
Primary Completion (ANTICIPATED)
January 1, 2022
Study Completion (ANTICIPATED)
January 1, 2022
Study Registration Dates
First Submitted
December 27, 2019
First Submitted That Met QC Criteria
January 15, 2020
First Posted (ACTUAL)
January 18, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 15, 2020
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chinese ASZQ-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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