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

Phase 4

• Conditions: Intrauterine Adhesions; Infertility; Endometrial Dysplasia
• Interventions: Procedure: autologous bone marrow stem cells

• Registration Number: NCT02204358
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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

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 Timeline

• Study Start: 2012-01
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study First Submitted: 2014-07-26
• Study First Submitted QC: 2014-07-28
• Last Update Submitted: 2014-07-28
• Study First Posted: 2014-07-30
• Last Update Posted: 2014-07-30
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous bone marrow stem cells	autologous bone marrow stem cells	Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.

Primary Outcome Measures

Name	Time	Method
Reduction of intrauterine scar area,the change of intrauterine adhesion	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

Secondary Outcome Measures

Name	Time	Method
The change of endometrial thickness	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.
menstrual blood volume The change of menstrual blood volume	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.

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China