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

Not Applicable

Completed

• Conditions: Intrauterine Adhesion; Thin Endometrium
• Interventions: Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold

• Registration Number: NCT03724617
• Lead Sponsor: Sir Run Run Shaw Hospital

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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-26
• Study Start: 2018-10-29
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-04-10
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stem cell therapy	umbilical cord mesenchymal stem cells combined with collagen scaffold	-

Primary Outcome Measures

Name	Time	Method
the change of endometrial thickness	Change from Baseline endometrial thickness at 6 months	B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.

Secondary Outcome Measures

Name	Time	Method
pregnancy rate	pregnancy rate at 1 year	pregnancy rate = (pregnancy / observations) × 100%
live birth rate	live birth rate at 1 year	live birth rate = (live births / observations) × 100%
abortion rate	abortion rate at 1 year	abortion rate = (number of abortions / observations) × 100%

Trial Locations

Locations (1)

Sir Run Run Shaw hopital,School of medicine,Zhejiang University; 🇨🇳 Hangzhou, China