Clinical trial NCT04232592: Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions
Official title: Clinical Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Cells in the Treatment of Moderate and Severe Intrauterine Adhesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Intrauterine Adhesion
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Tongji Hospital
First posted: 2020-01-18
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells
timeFrame: Within 48 weeks after surgery
Secondary outcomes:
measure: Normal recovery rate of endometrial thickness
timeFrame: 12 months
measure: recurrence rate of intrauterine adhesions
timeFrame: 12 months
measure: Intrauterine adhesions score
timeFrame: 12 months
measure: The endometrial biopsies for CD31
timeFrame: 12 months
measure: Menstrual volume change
timeFrame: 12 months
measure: Clinical pregnancy rate
timeFrame: 12 months
measure: The endometrial biopsies for estrogen
timeFrame: 12 months
measure: The endometrial biopsies for Ki67
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Zoology, Chinese Academy of Sciences
name: Qi Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
References: