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

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 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.

Study Overview

• Status: Completed
• Conditions: Infertility; Intrauterine Adhesions
• Intervention / Treatment: Procedure: UC-MSCs therapy

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
live birth rate	A baby born alive after 20 weeks gestation was classified as a live birth.	30 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of menstrual blood volume	Understanding the menstrual blood volume after surgery comparing with pre-operation.	baseline and 1 month

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: Institute of genetic development, Chinese Academy of Sciences; Institute of Zoology, Chinese Academy of Sciences
• Investigators: Principal Investigator: Yali HU, MD,PhD, Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2014
• Primary Completion (Actual): January 28, 2015
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: December 7, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (Estimate): December 10, 2014

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 22, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Infertility; Tissue Adhesions
• Other Study ID Numbers: 20141206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO