Trial | NCT03237442  Report issue

Title

Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
Placebo-Controlled,Randomized,Double-blind Trial of Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
Study Started
Jan 01
2018
Anticipated
Primary Completion
Dec 30
2018
Anticipated
Study Completion
Jun 30
2019
Anticipated
Last Update
Aug 02
2017

Biological human umbilical cord mesenchymal stem cells

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

Biological placebo

Saline injection

group 1 Experimental

group 2 Active Comparator

Criteria 

Inclusion Criteria:

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.

Exclusion Criteria:

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.
No Results Posted