NCT03386708

Brief Summary

The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Healing Poor after Uterus Injury, and exploring the possible mechanisms of umbilical cord mesenchymal stem cell therapy in Healing Poor After Uterus Injury disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2018

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

December 12, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2021

Completed
Last Updated

February 4, 2022

Status Verified

September 1, 2021

Enrollment Period

2.7 years

First QC Date

December 12, 2017

Last Update Submit

January 25, 2022

Conditions

Uterus; Injury

Keywords

Healing Poor After Uterus Injury, Mesenchymal Stem Cell

Outcome Measures

Primary Outcomes (1)

  • Intrauterine adhesion patients efficacy evaluation

    Evaluate the efficacy by calculating the thickness of endometrium, the equation is, Efficacy = (thickness of endometrium after treatment - thickness of endometrium before treatment)/thickness of endometrium before treatment \* 100% Classified the efficacy in 4 grade as follow, A. Recovery, efficacy 86% - 100%; B. Obvious improve, efficacy 46% - 85%; C. Improve, efficacy 16% -45%; D. Invalid, efficacy \< 16% Grade A, B, and C is proposed to be effective.

    12 months

Secondary Outcomes (4)

  • Incision lacuna and incision diverticulum patients efficacy evaluation

    12 months

  • Ultrasound of uterus evaluation

    12 months

  • Hysteroscopy evaluation

    12 months

  • Pain score

    12 months

Study Arms (1)

hUC-MSC intrauterine injection group

EXPERIMENTAL

Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#)

Procedure: intrauterine injectionBiological: human umbilical cord mesenchymal stem cell

Interventions

intrauterine injectionPROCEDURE

intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times

hUC-MSC intrauterine injection group
human umbilical cord mesenchymal stem cellBIOLOGICAL

2 \* 10\^7 cells (2ml)

hUC-MSC intrauterine injection group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female, with BMI 18-24 kg/m\^2
  • Meet the clinical standard of Healing Poor After Uterus Injury
  • Non smoker
  • Do not accept stem cells treatment in 6 months
  • Participants or their family members sign the consent form of this study

You may not qualify if:

  • Pregnant or breast feeding women
  • Age \<18 or \>40
  • Refuse to sign the consent form
  • Patients with underlying risk of medical disease history: history of diabetes, serious cardiovascular disease, severe infection, alimentary tract hemorrhage, etc.
  • Serum with HIV, syphilis antibody positive
  • Severe mental disease, cognitive disorder patients
  • Other severe system or organ organic disease
  • Participate other clinical experiments in 3 months
  • Ovarian and pituitary dysfunction diseases
  • With some other conditions that doctor propose not to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Related Publications (1)

  • Huang J, Li Q, Yuan X, Liu Q, Zhang W, Li P. Intrauterine infusion of clinically graded human umbilical cord-derived mesenchymal stem cells for the treatment of poor healing after uterine injury: a phase I clinical trial. Stem Cell Res Ther. 2022 Mar 3;13(1):85. doi: 10.1186/s13287-022-02756-9.

    PMID: 35241151DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Weishe Zhang

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 29, 2017

Study Start

October 1, 2018

Primary Completion

June 1, 2021

Study Completion

September 21, 2021

Last Updated

February 4, 2022

Record last verified: 2021-09

Locations

CN(1)