Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells

July 28, 2014 updated by: Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Clinical Study of the Treatment of Infertility Caused by Severe Intrauterine Adhesions by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells

Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide clinical evidence for the treatment of uterine infertility

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 no effective treatment to the infertility caused by severe intrauterine adhesions or endometrial dysplasia which affects embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe intrauterine adhesions.Collagen is the main component of the extracellular matrix with good biocompatibility, and it has been approved for the reparation of skin and oral mucosa by State Food and Drug Administration. Bone marrow stem cells have been used in the clinical treatment of blood diseases, and achieved good results. In this study, collagen scaffold and autologous bone marrow stem cells are combined, and they showed good biological safety

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower hospital
        • Contact:
          • Yali HU, MD,PhD
          • Phone Number: 66808 02583304616
          • Email: dtylhu@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Infertility caused by serious intrauterine adhesions or endometrial dysplasia
  • Hysteroscopy examination confirmed intrauterine adhesions or endometrial dysplasia
  • Monitoring of endometrial cycle
  • Sign a consent form
  • Follow the test plan and follow-up process

Exclusion Criteria:

  • Abnormal chromosome karyotype
  • Congenital uterine malformations
  • Severe endometriosis
  • Severe adenomyosis
  • Contraindications to pregnancy
  • Contraindications to bone marrow collection
  • Contraindications to hormone replacement therapy
  • Medical history of pelvic tumors or receiving pelvic radiotherapy
  • Unable to adhere to the hospital examination and follow-up, or carrying on other treatment during follow-up period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autologous bone marrow stem cells
Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.
Procedure: autologous bone marrow stem cells

Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.

If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.

Other Names:
  • collagen scaffold
  • infertility
  • severe intrauterine adhesions
  • endometrial dysplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 month
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.
up to 2 months
menstrual blood volume 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.
baseline and 1 month

Other Outcome Measures

Outcome Measure
Time Frame
rate of pregnancy
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Yali HU, MD,PhD, Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 26, 2014

First Submitted That Met QC Criteria

July 28, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 28, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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