UnknownPhase 1

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

32 participantsStarted 2020-01

Plain-language 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.

Who can participate

Age range

18 Years – 38 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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., …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of different Adverse Events of transplantation of mesenchymal cells from human embryonic stem cells

Timeframe: Within 48 weeks after surgery

Trial details

NCT IDNCT04232592

SponsorQi Zhou

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-01

Contact for this trial

Liu Wang, Doctor

+86-01064807858 wangliu@ioz.ac.cn

View on ClinicalTrials.gov More Intrauterine Adhesion trials