NCT03237442

Brief Summary

Ocular chemical burn is one of the causes of vision loss in China, and there are no satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal burn in human.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

12 months

First QC Date

July 30, 2017

Last Update Submit

August 1, 2017

Conditions

Ocular Corneal Burn

Outcome Measures

Primary Outcomes (1)

  • the percent of cornea perforation

    3 months

Study Arms (2)

group 1

EXPERIMENTAL
Biological: human umbilical cord mesenchymal stem cells

group 2

ACTIVE COMPARATOR
Biological: placebo

Interventions

human umbilical cord mesenchymal stem cellsBIOLOGICAL

human UC-MSCs: 0.2ml(about 2\*10\^6 cells) subconjunctival injection

group 1
placeboBIOLOGICAL

Saline injection

group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • must be ocular burns including chemically burned or the thermally burned;
  • the subjects are willing to accept this research, and promise to coordinate with the researchers during the follow up period;
  • the subjects should abide by the laws and rules of the study.

You may not qualify if:

  • the visual acuity is blind in any of the eye;
  • have corneal perforation or have the corneal perforation tendency;
  • have been accepted surgery on eyeball after trauma;
  • IOP\>=25 mmHg even after antiglaucoma;
  • have the history of other corneal disease or surgery;
  • have the history of radiotherapy or surgery in the eyeball;
  • associated with corneal ulcer or endoophthalmitis;
  • uncontrolled hypertension(\>=150/95 mmHg);
  • abnormal liver and renal function;
  • the pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Location

Central Study Contacts

Wanling Chen

CONTACT

0086-20-37792600chenwanling@saliai.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2017

First Posted

August 2, 2017

Study Start

January 1, 2018

Primary Completion

December 30, 2018

Study Completion

June 30, 2019

Last Updated

August 2, 2017

Record last verified: 2017-07

Locations

CN(1)