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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204358
• Other study ID #: 2012022
• Status: Recruiting
• Phase: Phase 4
• First received: July 26, 2014
• Last updated: July 28, 2014
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Yali Hu, MD PhD
• Phone: 02583304616
• Email: 819241652[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug AdministrationChina: National Natural Science FoundationChina: Ministry of HealthChina: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Dysplasia
• Infertility
• Intrauterine Adhesions
• Tissue Adhesions

Intervention

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.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of pregnancy		2 years	Yes
Primary	Reduction of intrauterine scar area,the change of intrauterine adhesion	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	Yes
Secondary	The change of endometrial thickness	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	Yes
Secondary	The change of endometrial thickness	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	Yes
Secondary	menstrual blood volume The change of menstrual blood volume	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	No