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

Not Applicable

Completed

• Conditions: Infertility; Intrauterine Adhesions
• Interventions: Procedure: UC-MSCs therapy

• Registration Number: NCT02313415
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Study Start: 2014-11-28
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-10
• Primary Completion: 2015-01-28
• Study Completion: 2017-08-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-22
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
live birth rate	30 months	A baby born alive after 20 weeks gestation was classified as a live birth.

Secondary Outcome Measures

Name	Time	Method
The change of endometrial thickness	up to 3 months	Measure the endometrial thickness during late proliferating phase by ultrasound
ongoing pregnant rate	30 months	The presence of at least one fetus with heart pulsation on ultrasound beyond 8 weeks
Reduction of intrauterine adhesion	3 months post-surgery	Hysteroscopic inspection to verify degree of adhesion

Trial Locations

Locations (1)

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