NCT03381807

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2020

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
2.7 years until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

November 27, 2017

Last Update Submit

October 25, 2020

Conditions

Intrauterine Adhesion

Outcome Measures

Primary Outcomes (2)

  • 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.

    at the 1, 3，6 and 9 months after surgery

  • 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.

    at the 1, 3，6 and 9 months after surgery

Secondary Outcomes (1)

  • pregnancy rate

    24 months

Study Arms (1)

TCRA and intrauterine infusion of hAESCs

EXPERIMENTAL

hAESCs is infused into uterine cavity after TCRA.

Biological: hAESCs

Interventions

hAESCsBIOLOGICAL

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

TCRA and intrauterine infusion of hAESCs

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Wang Liang

    The Second Affiliated Hospital of Medical College of Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Liang

CONTACT

0571-88783738liangzi1126@126.com

Liu Yang

CONTACT

0571-88783738liuyangzheda@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 22, 2017

Study Start

September 16, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2023

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations

CN(1)