Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium

NCT ID: NCT03724617

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2020-12-31

Brief Summary

This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.

Detailed Description

According to the medical history and the results of the examination, the selected cases were screened and the informed consent was signed. After hysteroscopy, the collagen/umbilical cord mesenchymal stem cell was spread on a foley catheter, and placed in the uterine cavity, and 5 ml of saline was filled into the balloon. B-ultrasound confirmed that the stent was attached to the uterine wall. The balloon was removed in situ after 1 week. We mainly compare the endometrial thickness before and 6 months after surgery.

Conditions

Thin Endometrium; Intrauterine Adhesion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stem cell therapy

Group Type: EXPERIMENTAL

umbilical cord mesenchymal stem cells combined with collagen scaffold

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.

2. Women aged 20-40 years with fertility requirements

3. Infertility patients who are treated in this hospital

4. 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.

5. 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.

6. HBVAg negative, HCV negative, HIV negative, syphilis negative

7. Normal bone marrow morphology, normal blood routine

8. Previously failed to receive relevant stem cell therapy

Exclusion Criteria

1. Those who cannot accept the treatment observation process required by the test

2. There are contraindications for hysteroscopic surgery;

3. 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

4. Patients with chromosomal abnormalities

5. contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.

6. Patients without fertility requirements

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaona Lin

senior doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaona Lin

Role: STUDY_CHAIR

Sir Run Run Shaw Hospital

Locations

Sir Run Run Shaw hopital,School of medicine,Zhejiang University

Hangzhou, , China

Countries

China

References

Zhang Y, Shi L, Lin X, Zhou F, Xin L, Xu W, Yu H, Li J, Pan M, Pan Y, Dai Y, Zhang Y, Shen J, Zhao L, Lu M, Zhang S. Unresponsive thin endometrium caused by Asherman syndrome treated with umbilical cord mesenchymal stem cells on collagen scaffolds: a pilot study. Stem Cell Res Ther. 2021 Jul 22;12(1):420. doi: 10.1186/s13287-021-02499-z.

Reference Type: DERIVED

PMID: 34294152 (View on PubMed)

Other Identifiers

SRRSHRMC20180924

Identifier Type: -

Identifier Source: org_study_id