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

Primary Purpose

Thin Endometrium, Intrauterine Adhesion

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
umbilical cord mesenchymal stem cells combined with collagen scaffold
Sponsored by
Sir Run Run Shaw Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thin Endometrium focused on measuring thin endometrium, Intrauterine Adhesion, stem cell, Collagen scaffold

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cell therapy

Arm Description

Outcomes

Primary Outcome Measures

the change of endometrial thickness
B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.

Secondary Outcome Measures

pregnancy rate
pregnancy rate = (pregnancy / observations) × 100%
live birth rate
live birth rate = (live births / observations) × 100%
abortion rate
abortion rate = (number of abortions / observations) × 100%

Full Information

First Posted
October 26, 2018
Last Updated
April 10, 2021
Sponsor
Sir Run Run Shaw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03724617
Brief Title
Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium
Official Title
Clinical Study of Stem Cells in the Treatment of Thin Endometrium
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thin Endometrium, Intrauterine Adhesion
Keywords
thin endometrium, Intrauterine Adhesion, stem cell, Collagen scaffold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stem cell therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
umbilical cord mesenchymal stem cells combined with collagen scaffold
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change of endometrial thickness
Description
B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.
Time Frame
Change from Baseline endometrial thickness at 6 months
Secondary Outcome Measure Information:
Title
pregnancy rate
Description
pregnancy rate = (pregnancy / observations) × 100%
Time Frame
pregnancy rate at 1 year
Title
live birth rate
Description
live birth rate = (live births / observations) × 100%
Time Frame
live birth rate at 1 year
Title
abortion rate
Description
abortion rate = (number of abortions / observations) × 100%
Time Frame
abortion rate at 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaona Lin
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sir Run Run Shaw hopital,School of medicine,Zhejiang University
City
Hangzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34294152
Citation
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.
Results Reference
derived

Learn more about this trial

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

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