ClinicalTrials.gg
Status unknownNCT03381807Updated Oct 28, 2020

Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion

An Early Phase 1 interventional study of hAESCs in Intrauterine Adhesion, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-10-28.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 44 studies in Gynatresia with a site in China — 11 open to participants now, 14 under way, none of them phase 3. Gynatresia · China.

Planned enrollment
39th of 41
20 · median 171
Started
2020
with 2 others
Phase 1
3 of 44
2 open now
Registered
18th of 44
by date

Among the 44 studies in Gynatresia with a site in China, this one is the 39th largest by planned enrollment of the 41 interventional ones that give a count, is one of 3 that started in 2020, is one of 3 in phase 1, and was the 18th registered.

Gynatresia

99 studies on the registry are indexed under Gynatresia; 23 are open to participants now.

Browse Gynatresia studies →

Open to participants now

11 of the 44 studies in Gynatresia with a site in China are open now. Recruiting first, the newest first:

6 more — sign in →

All 11 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 18 Gynatresia studies recruiting now, 1 (6%) sets no upper age limit and 17 (94%) stop at 75 or younger; none take children under 18; 5 take healthy volunteers.

This study: 20 Years to 45 Years · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 44 studies in Gynatresia with a site in China, or all of them as a file.
02

Study summary

This project will investigate the safety and effectiveness of human amniotic epithelial stem cells for treatment of severe refractory Asherman's syndrome.

Read the detailed description

Asherman's syndrome is an gynecological disorder caused by the destruction of the endometrium due to repeated or aggressive curettages and/or endometritis. As a result, there is a loss of functional endometrium in multiple areas and the uterine cavity is obliterated by intrauterine adhesions, which results in amenorrhea, hypomenorrhea, infertility and recurrent pregnancy loss. Transcervical resection of adhesion (TCRA) is the main treatment for Asherman's syndrome; so far the effect is usually poor in moderate to severe refractory cases.

Human amniotic epithelial stem cells (hAESCs) are derived from human amniotic epithelium. hAESCs retain the characteristics approximating to embryonic stem cells. Animal experiments have shown that the endometrial thickness and fertility of mice was significantly improved after intrauterine therapy with hAESCs. To further explore the role of hAESCs in Asherman's syndrome patients, this project will evaluate the safety of hAESCs and find an effective treatment protocols.

03

Conditions studied

  • Intrauterine Adhesion

Browse trials for

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Previously diagnosed as uterine adhesion, after the operation of TCRA and the postoperatively standardized hormonal replacement therapy(HRT) , recently diagnosed with Asherman's syndrome or endometrial atrophy(EA);
    1. According to the American Fertility Society(AFS) classification in 1988, patients are diagnosed of AS or EA stageⅢ-Ⅳ confirmed by hysteroscopy;
    1. Elimination of infertility, recurrent spontaneous abortion or hypomenorrhea caused by other diseases;
    1. Be willing to maintain an HRT cycle medication throughout the study, unless it is not tolerated;
    1. Normal blood coagulation, liver, heart, and kidney function, absence of , or C, syphilis and psychiatric pathology;
    1. Be willing to complete the study and sign the consent form.

Exclusion criteria

Exclusion Criteria:

    1. Patients with severe internal disease;
    1. The patients are suffering from gynecologic inflammation or active genital tubercle bacillus;
    1. The patient has other uterine diseases or the abnormal uterine cavity which can't be restored by surgery;
    1. Infertility due to a man's cause;
    1. The patient has a previous history of cancer and is undergoing radiotherapy or chemotherapy;
    1. positive
    1. Active or C infection, syphilis seropositive
    1. Laboratory routine check index abnormality, such as (hemoglobin)\<8.0 g/dL,WBC(white blood cell count)\<3,000/ml, counts\<75 000/mm3, (glutamic oxalacetic transaminase)>(upper limit of normal),ALT(Glutamic pyruvic transaminase)>ULN and so on;
    1. Patients have any complications that may interfere with safety or efficacy or predict of less than 24 months;
    1. Mental illness in the past 6 months;
    1. Patients have a history of drug or alcohol abuse or dependence in the past two years;
    1. Unable or unwilling to give .
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    TCRA and intrauterine infusion of hAESCs

    hAESCs is infused into uterine cavity after TCRA.

    Biological: hAESCs

Interventions

  • BiologicalhAESCs

    5\*10\^7 hAESCs is infused into uterine cavity with TCRA on Day0, Day7 and after the first menstruation

06

What researchers measure

Primary outcomes

  1. changes of Endometrial thickness

    Measure the endometrial thickness during periovulatory period on ultrasound by the same trained medical sonographers at 1,3,6 and 9 months after surgery, comparing with pre-operation.

    Time frame: at the 1, 3,6 and 9 months after surgery

  2. changes of Menstrual blood volume

    Estimate the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days to menstruation at 1, 3, 6, 9 months after surgery, which will be compared with pre-operation.

    Time frame: at the 1, 3,6 and 9 months after surgery

Secondary outcomes

  1. pregnancy rate

    Ultrasound reveals that the fetus had a heart activity

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310009, China
    Recruiting
    • YANG LIU · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2020 (actual). Primary completion is estimated for Sep 2022, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2017
First posted
Dec 22, 2017
StartActual
Sep 16, 2020
Primary completionEst.
Sep 1, 2022
CompletionEst.
Sep 1, 2023
Last update
Oct 28, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03381807
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Responsible party
Sponsor
First posted
Dec 22, 2017
Start date
Sep 16, 2020
Primary completion
Sep 1, 2022 (estimated)
Completion
Sep 1, 2023 (estimated)
Last update
Oct 28, 2020

Study contacts

Wang Liang
Contact
liangzi1126@126.com
0571-88783738
Liu Yang
Contact
liuyangzheda@163.com
0571-88783738
Wang Liang
principal investigator · The Second Affiliated Hospital of Medical College of Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion