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

NCT04232592 | Unknown Phase 1 DMC

• 1 other identifier: Chinese ASZQ-005
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intrauterine Adhesion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

Study Arms (2)

Stem cell preparation solution injection group

EXPERIMENTAL

The solution of stem cells preparation will be injected.

Biological: Inject a solution of stem cell preparation

Injected stem cell group

EXPERIMENTAL

The stem cells will injected.

Biological: Inject stem cells

Interventions

Inject a solution of stem cell preparation BIOLOGICAL

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

Stem cell preparation solution injection group

Inject stem cells BIOLOGICAL

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

Injected stem cell group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≤ 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qi Zhou: lead
• Tongji Hospital: collaborator

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Qi Zhou, Doctor

  Institute of Zoology, Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Wang, Doctor

CONTACT

+86-01064807858; wangliu@ioz.ac.cn

Jie Hao, Doctor

CONTACT

+86-01062558737; haojie@ioz.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Institute of zoology, chinese academy of sciences, and vice president of medical school， University of chinese academy of sciences

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 18, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 18, 2020

Record last verified: 2019-12