NCT02313415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

December 7, 2014

Last Update Submit

October 22, 2017

Conditions

InfertilityIntrauterine Adhesions

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    A baby born alive after 20 weeks gestation was classified as a live birth.

    30 months

Secondary Outcomes (3)

  • Reduction of intrauterine adhesion

    3 months post-surgery

  • The change of endometrial thickness

    up to 3 months

  • ongoing pregnant rate

    30 months

Other Outcomes (1)

  • The change of menstrual blood volume

    baseline and 1 month

Study Arms (1)

UC-MSCs therapy

EXPERIMENTAL

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

Procedure: UC-MSCs therapy

Interventions

UC-MSCs therapyPROCEDURE

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.

UC-MSCs therapy

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • have hysteroscopic contraindications
  • Chromosome karyotype abnormalities
  • Congenital uterine malformations
  • Severe adenomyosis
  • Contraindications to estradiol treatment
  • Medical history of pelvic tumors or receiving pelvic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

  • 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.

    PMID: 29996892DERIVED

MeSH Terms

Conditions

InfertilityGynatresia

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Yali HU, MD,PhD

    Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: treatment of infertility caused by recurrent intrauterine adhesions by collagen scaffold loaded with UC-MSCs
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 10, 2014

Study Start

November 28, 2014

Primary Completion

January 28, 2015

Study Completion

August 31, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)