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

NCT ID: NCT04232592

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2022-01-31

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.

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.

Conditions

Intrauterine Adhesion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem cell preparation solution injection group

The solution of stem cells preparation will be injected.

Group Type: EXPERIMENTAL

Inject a solution of stem cell preparation

Intervention Type: BIOLOGICAL

The control group was injected with a solution of stem cell preparation

Injected stem cell group

The stem cells will injected.

Group Type: EXPERIMENTAL

Inject stem cells

Intervention Type: BIOLOGICAL

Three dose groups were designed: low dose group, medium dose group and high dose group.

Interventions

Inject a solution of stem cell preparation

The control group was injected with a solution of stem cell preparation

Intervention Type: BIOLOGICAL

Inject stem cells

Three dose groups were designed: low dose group, medium dose group and high dose group.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: collaborator

Qi Zhou

OTHER_GOV

Sponsor Role: lead

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qi Zhou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Institute of Zoology, Chinese Academy of Sciences

Central Contacts

Liu Wang, Doctor

Role: CONTACT

wangliu@ioz.ac.cn

+86-01064807858

Jie Hao, Doctor

Role: CONTACT

haojie@ioz.ac.cn

+86-01062558737

Other Identifiers

Chinese ASZQ-005

Identifier Type: -

Identifier Source: org_study_id