Ocular Corneal Burn
Conditions
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.
Interventions
BIOLOGICALhuman umbilical cord mesenchymal stem cells
human UC-MSCs: 0.2ml(about 2\*10\^6 cells) subconjunctival injection
BIOLOGICALplacebo
Saline injection
Sponsors
Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percent of cornea perforation | 3 months |
Countries
China
Contacts
Primary ContactWanling Chen
Outcome results
None listed