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The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03592849
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
38.7
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring.

Condition or Disease Intervention/Treatment Phase
  • Procedure: UC-MSCs therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
Actual Study Start Date :
Sep 10, 2018
Actual Primary Completion Date :
Jan 31, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: UC-MSCs therapy

transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring

Procedure: UC-MSCs therapy
After history taking, physical examination, ultrasound examination and hysteroscopy examination，infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory.
Other Names:
  • collagen scaffold

    		•

    Outcome Measures

    Primary Outcome Measures

    1. endometrial thickness [12 months]

      endometrium thickness evaluated by transvaginal sonography during late proliferating phase

    Secondary Outcome Measures

    1. ongoing pregnancy rate [24 months]

      the presence of a living intrauterine fetus on TVU at the 12th week of gestation

    2. live birth rate [24 months]

      a live born baby ≥28 weeks of gestation

    3. endometrial blood flow [6 months]

      uterine blood flow evaluated by transvaginal sonography

    Other Outcome Measures

    1. menstrual blood volume [baseline and 6 month postoperation]

      the change of menstrual blood volume after surgery compared with pre-operation

    2. adverse event rate [30 months]

      the occurrence of infections、allergies、abdominal pain postoperation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Infertile patients with clear fertility desires

    2. Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective

    3. 20-42 years old

    4. Normal ovarian function or with frozen embryos

    5. Willing to actively cooperate with postoperative follow-up

    Exclusion Criteria:

    1. With abnormal chromosome karyotype

    2. With other uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis

    3. Systemic diseases: hypertension, diabetes, and so on

    4. Contraindications to pregnancy

    5. Contraindications to hormone replacement therapy

    6. Medical history of pelvic tumors or receiving pelvic radiotherapy

    7. Involved in other clinical studies

    8. Unable to adhere to the follow-up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanjing Drum Tower Hospital Nanjing Jiangsu China 210008

    Sponsors and Collaborators

    • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Investigators

    • Principal Investigator: Yali Hu, MD,PhD, The Affiliated Drum Tower Hospital of Nanjing University Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yali Hu, Professor，Chief Physician of Obstetrics and Gynecology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    ClinicalTrials.gov Identifier:
    NCT03592849
    Other Study ID Numbers:
    • SC201700101
    First Posted:
    Jul 19, 2018
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yali Hu, Professor，Chief Physician of Obstetrics and Gynecology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    thin endometrium
    infertility
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Sep 1, 2021