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

Infertility Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313415
• Other study ID #: 20141206
• Status: Completed
• Phase: N/A
• First received: December 7, 2014
• Last updated: October 22, 2017
• Start date: November 28, 2014
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2017
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 31, 2017
• Est. primary completion date: January 28, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Intrauterine Adhesions
• Tissue Adhesions

Intervention

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.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Institute of genetic development, Chinese Academy of Sciences, Institute of zoology, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change of menstrual blood volume	Understanding the menstrual blood volume after surgery comparing with pre-operation.	baseline and 1 month
Primary	live birth rate	A baby born alive after 20 weeks gestation was classified as a live birth.	30 months
Secondary	Reduction of intrauterine adhesion	Hysteroscopic inspection to verify degree of adhesion	3 months post-surgery
Secondary	The change of endometrial thickness	Measure the endometrial thickness during late proliferating phase by ultrasound	up to 3 months
Secondary	ongoing pregnant rate	The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks	30 months