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

Clinical Study of Stem Cells in the Treatment of Thin Endometrium

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.

Study Overview

• Status: Completed
• Conditions: Intrauterine Adhesion; Thin Endometrium
• Intervention / Treatment: Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Sir Run Run Shaw hopital,School of medicine,Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy rate	pregnancy rate = (pregnancy / observations) × 100%	pregnancy rate at 1 year
live birth rate	live birth rate = (live births / observations) × 100%	live birth rate at 1 year
abortion rate	abortion rate = (number of abortions / observations) × 100%	abortion rate at 1 year

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Investigators: Study Chair: Xiaona Lin, Sir Run Run Shaw Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: stem cell; Intrauterine Adhesion; thin endometrium; Collagen scaffold
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: SRRSHRMC20180924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No