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

Nanjing University

Status: Completed

Conditions: Infertility; Intrauterine Adhesions

Treatments: Procedure: UC-MSCs therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02313415

20141206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

UC-MSCs therapy

Experimental group

Description:

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

Treatment:

Procedure: UC-MSCs therapy