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

Primary Purpose

Infertility, Intrauterine Adhesions

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
UC-MSCs therapy
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing Drum Tower Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UC-MSCs therapy

Arm Description

transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions

Outcomes

Primary Outcome Measures

live birth rate
A baby born alive after 20 weeks gestation was classified as a live birth.

Secondary Outcome Measures

Reduction of intrauterine adhesion
Hysteroscopic inspection to verify degree of adhesion
The change of endometrial thickness
Measure the endometrial thickness during late proliferating phase by ultrasound
ongoing pregnant rate
The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks

Full Information

First Posted
December 7, 2014
Last Updated
October 22, 2017
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Institute of genetic development, Chinese Academy of Sciences, Institute of zoology, Chinese Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02313415
Brief Title
Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 28, 2014 (Actual)
Primary Completion Date
January 28, 2015 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Institute of genetic development, Chinese Academy of Sciences, Institute of zoology, Chinese Academy of Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Intrauterine Adhesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UC-MSCs therapy
Arm Type
Experimental
Arm Description
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions
Intervention Type
Procedure
Intervention Name(s)
UC-MSCs therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
live birth rate
Description
A baby born alive after 20 weeks gestation was classified as a live birth.
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Reduction of intrauterine adhesion
Description
Hysteroscopic inspection to verify degree of adhesion
Time Frame
3 months post-surgery
Title
The change of endometrial thickness
Description
Measure the endometrial thickness during late proliferating phase by ultrasound
Time Frame
up to 3 months
Title
ongoing pregnant rate
Description
The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks
Time Frame
30 months
Other Pre-specified Outcome Measures:
Title
The change of menstrual blood volume
Description
Understanding the menstrual blood volume after surgery comparing with pre-operation.
Time Frame
baseline and 1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yali HU, MD,PhD
Organizational Affiliation
Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29996892
Citation
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.
Results Reference
derived

Learn more about this trial

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

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