Clinical trial NCT02313415: Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Intrauterine Adhesions
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Institute of genetic development, Chinese Academy of Sciences
name: Institute of Zoology, Chinese Academy of Sciences
First posted: 2014-12-10
Enrollment: 26
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: live birth rate
timeFrame: 30 months
Secondary outcomes:
measure: Reduction of intrauterine adhesion
timeFrame: 3 months post-surgery
measure: The change of endometrial thickness
timeFrame: up to 3 months
measure: ongoing pregnant rate
timeFrame: 30 months
Other outcomes:
measure: The change of menstrual blood volume
timeFrame: baseline and 1 month
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Yali HU, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cao Y, Sun H, Zhu H, Zhu X, Tang X, Yan G, Wang J, Bai D, Wang J, Wang L, Zhou Q, Wang H, Dai C, Ding L, Xu B, Zhou Y, Hao J, Dai J, Hu Y. Allogeneic cell therapy using umbilical cord MSCs on collagen scaffolds for patients with recurrent uterine adhesion: a phase I clinical trial. Stem Cell Res Ther. 2018 Jul 11;9(1):192. doi: 10.1186/s13287-018-0904-3.