Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03724617 |
Recruitment Status :
Completed
First Posted : October 30, 2018
Last Update Posted : April 13, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thin Endometrium Intrauterine Adhesion | Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Study of Stem Cells in the Treatment of Thin Endometrium |
Actual Study Start Date : | October 29, 2018 |
Actual Primary Completion Date : | June 30, 2020 |
Actual Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: stem cell therapy |
Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold
3-7 days after the end of menstruation, we underwent hysteroscopic exploration and separation if there was intrauterine adhesions. Intraoperative endometrial biopsy, recording biopsy location, endometrial specimens sent to HE examination and immunohistochemistry (vwf detection of microvessel density). The umbilical cord mesenchymal stem cell combined with collagen scaffold was spread on the balloon scaffold and placed in the uterine cavity. 5 ml of saline was filled into the balloon, and B-ultrasound confirmed that the scaffold was attached to the uterine wall. The patient was hospitalized for 2 hours and the patient's vital signs were recorded. |
- the change of endometrial thickness [ Time Frame: Change from Baseline endometrial thickness at 6 months ]B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.
- pregnancy rate [ Time Frame: pregnancy rate at 1 year ]pregnancy rate = (pregnancy / observations) × 100%
- live birth rate [ Time Frame: live birth rate at 1 year ]live birth rate = (live births / observations) × 100%
- abortion rate [ Time Frame: abortion rate at 1 year ]abortion rate = (number of abortions / observations) × 100%

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.
- Women aged 20-40 years with fertility requirements
- Infertility patients who are treated in this hospital
- After more than 2 times of hysteroscopic adhesion separation surgery, the uterine cavity morphology has basically returned to normal. The patient has a normal menstrual cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the endometrium is 5.5 mm in 6 cycles by ultrasound.
- or receive adjuvant reproductive treatment, the endometrial thickness is less than 5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs up to 8mg / day is invalid.
- HBVAg negative, HCV negative, HIV negative, syphilis negative
- Normal bone marrow morphology, normal blood routine
- Previously failed to receive relevant stem cell therapy
Exclusion Criteria:
- Those who cannot accept the treatment observation process required by the test
- There are contraindications for hysteroscopic surgery;
- congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect embryo implantation; the investigators judged that there are other uterine factors that are not suitable for embryo implantation
- Patients with chromosomal abnormalities
- contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.
- Patients without fertility requirements

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724617
China | |
Sir Run Run Shaw hopital,School of medicine,Zhejiang University | |
Hangzhou, China |
Study Chair: | Xiaona Lin | Sir Run Run Shaw Hospital |
Responsible Party: | Xiaona Lin, senior doctor, Sir Run Run Shaw Hospital |
ClinicalTrials.gov Identifier: | NCT03724617 |
Other Study ID Numbers: |
SRRSHRMC20180924 |
First Posted: | October 30, 2018 Key Record Dates |
Last Update Posted: | April 13, 2021 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
thin endometrium Intrauterine Adhesion stem cell Collagen scaffold |
Tissue Adhesions Cicatrix Fibrosis Pathologic Processes |