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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

NCT03592849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-09-28

No results posted yet for this study

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.

Conditions

  • Infertility, Female
  • Endometrium

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2021-01-31
Completion
2022-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03592849 on ClinicalTrials.gov