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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

Tracking Information
First Submitted Date  ICMJE December 7, 2014
First Posted Date  ICMJE December 10, 2014
Last Update Posted Date October 24, 2017
Actual Study Start Date  ICMJE November 28, 2014
Actual Primary Completion Date January 28, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2017)
live birth rate [ Time Frame: 30 months ]
A baby born alive after 20 weeks gestation was classified as a live birth.
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
Reduction of intrauterine scar area,the change of intrauterine adhesion [ Time Frame: up to 3 months ]
Hysteroscope,understanding improvement of uterine cavity form,the degree and nature of adhesion or the vanishment of intrauterine adhesion,and the reduction of scar and its area,comparing with pre-operation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2017)
  • Reduction of intrauterine adhesion [ Time Frame: 3 months post-surgery ]
    Hysteroscopic inspection to verify degree of adhesion
  • The change of endometrial thickness [ Time Frame: up to 3 months ]
    Measure the endometrial thickness during late proliferating phase by ultrasound
  • ongoing pregnant rate [ Time Frame: 30 months ]
    The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • The change of endometrial thickness [ Time Frame: up to 1 month ]
    Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.
  • The change of endometrial thickness [ Time Frame: up to 2 months ]
    Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.
  • The change of menstrual blood volume [ Time Frame: baseline and 1 month ]
    Understanding the menstrual blood volume after surgery,the number of sanitary napkins per day,and number of days,comparing with pre-operation.
Current Other Pre-specified Outcome Measures
 (submitted: October 22, 2017)
The change of menstrual blood volume [ Time Frame: baseline and 1 month ]
Understanding the menstrual blood volume after surgery comparing with pre-operation.
Original Other Pre-specified Outcome Measures
 (submitted: December 9, 2014)
Rate of pregnancy [ Time Frame: 2 years ]
 
Descriptive Information
Brief Title  ICMJE Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Infertility
  • Intrauterine Adhesions
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: UC-MSCs therapy
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions
Intervention: Procedure: UC-MSCs therapy
Publications * Cao Y, Sun H, Zhu H, Zhu X, Tang X, Yan G, Wang J, Bai D, Wang J, Wang L, Zhou Q, Wang H, Dai C, Ding L, Xu B, Zhou Y, Hao J, Dai J, Hu Y. Allogeneic cell therapy using umbilical cord MSCs on collagen scaffolds for patients with recurrent uterine adhesion: a phase I clinical trial. Stem Cell Res Ther. 2018 Jul 11;9(1):192. doi: 10.1186/s13287-018-0904-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2017)
26
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2014)
20
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date January 28, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02313415
Other Study ID Numbers  ICMJE 20141206
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sponsor  ICMJE The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators  ICMJE
  • Institute of genetic development, Chinese Academy of Sciences
  • Institute of zoology, Chinese Academy of Sciences
Investigators  ICMJE
Principal Investigator: Yali HU, MD,PhD Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
PRS Account The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP