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Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells

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ClinicalTrials.gov Identifier: NCT02313415
Recruitment Status : Completed
First Posted : December 10, 2014
Last Update Posted : October 24, 2017
Sponsor:
Collaborators:
Institute of genetic development, Chinese Academy of Sciences
Institute of zoology, Chinese Academy of Sciences
Information provided by (Responsible Party):
Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
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Brief Summary:
Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to provide clinical evidence of safety and effectiveness for the treatment of uterine infertility.

Condition or disease Intervention/treatment Phase
Infertility Intrauterine Adhesions Procedure: UC-MSCs therapy Not Applicable

Detailed Description:
Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is limited treatment to the infertility caused by severe IUA especially recurrent IUA after adhesiolysis which hinders embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe recurrent intrauterine adhesions. Collagen is the main component of the extracellular matrix with good biocompatibility, UC-MSCs have been used in the clinical treatment of diseases, and achieved good results. In this study, collagen scaffold and umbilical cord blood-derived mesenchymal stem cells are combined, and they showed good biological safety.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the Treatment of Infertility Caused by Recurrent Intrauterine Adhesions by Collagen Scaffold Loaded With Umbilical Cord -Derived Mesenchymal Stem Cells (UC-MSCs)
Actual Study Start Date : November 28, 2014
Actual Primary Completion Date : January 28, 2015
Actual Study Completion Date : August 31, 2017

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: UC-MSCs therapy
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions
 Procedure: UC-MSCs therapy
Before considering whether patients meet the inclusion criteria, they are diagnosed as intrauterine adhesions with at least one unsuccessful hysteroscopic surgery. And after that there will be history taking, physical examination, ultrasound examination and hysteroscopy examination. If they agree to participate, they will receive separation of adhesions by hysteroscopy surgery and endometrial biopsies, then a collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity. The procedure was performed after taking 6 mg/day × 10 days Progynova, continuous administration of the same dosage Progynova for 30 days and 60mg of progesterone were injected on the 30th day post-operation. Postoperative observation including ultrasound examination once a month for 3 times and hysteroscopy after 3 months. The doctor will select an appropriate time for pregnancy and follow-up including requiring patients to do some unscheduled visits.


Outcome Measures
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Primary Outcome Measures :
  1. live birth rate [ Time Frame: 30 months ]
    A baby born alive after 20 weeks gestation was classified as a live birth.


Secondary Outcome Measures :
  1. Reduction of intrauterine adhesion [ Time Frame: 3 months post-surgery ]
    Hysteroscopic inspection to verify degree of adhesion

  2. The change of endometrial thickness [ Time Frame: up to 3 months ]
    Measure the endometrial thickness during late proliferating phase by ultrasound

  3. ongoing pregnant rate [ Time Frame: 30 months ]
    The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks


Other Outcome Measures:
  1. The change of menstrual blood volume [ Time Frame: baseline and 1 month ]
    Understanding the menstrual blood volume after surgery comparing with pre-operation.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Secondary infertility or failure of embryo transfer caused by recurrent intrauterine adhesions who desired to be pregnant
  • Hysteroscopy examination confirmed intrauterine adhesions
  • Sign a consent form
  • Follow the test plan and follow-up process

Exclusion Criteria:

  • have hysteroscopic contraindications
  • Chromosome karyotype abnormalities
  • Congenital uterine malformations
  • Severe adenomyosis
  • Contraindications to estradiol treatment
  • Medical history of pelvic tumors or receiving pelvic radiotherapy
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): NCT02313415


Locations
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China, Jiangsu
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Institute of genetic development, Chinese Academy of Sciences
Institute of zoology, Chinese Academy of Sciences
Investigators
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Principal Investigator: Yali HU, MD,PhD Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yali Hu, MD,PhD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT02313415    
Other Study ID Numbers: 20141206
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infertility
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes