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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
Sponsor:
Information provided by (Responsible Party):
Xiaona Lin, Sir Run Run Shaw Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thin Endometrium Intrauterine Adhesion Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold Not Applicable

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. pregnancy rate [ Time Frame: pregnancy rate at 1 year ]
    pregnancy rate = (pregnancy / observations) × 100%

  2. live birth rate [ Time Frame: live birth rate at 1 year ]
    live birth rate = (live births / observations) × 100%

  3. abortion rate [ Time Frame: abortion rate at 1 year ]
    abortion rate = (number of abortions / observations) × 100%


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China
Sir Run Run Shaw hopital,School of medicine,Zhejiang University
Hangzhou, China
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Investigators
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Study Chair: Xiaona Lin Sir Run Run Shaw Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaona Lin, Sir Run Run Shaw Hospital:
thin endometrium
Intrauterine Adhesion
stem cell
Collagen scaffold
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes