Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

Phase 1

• Conditions: Ocular Corneal Burn
• Interventions: Biological: human umbilical cord mesenchymal stem cells; Biological: placebo

• Registration Number: NCT03237442
• Lead Sponsor: Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-30
• Study First Submitted QC: 2017-08-01
• Last Update Submitted: 2017-08-01
• Study First Posted: 2017-08-02
• Last Update Posted: 2017-08-02
• Study Start: 2018-01-01
• Primary Completion: 2018-12-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	human umbilical cord mesenchymal stem cells	-
group 2	placebo	-

Primary Outcome Measures

Name	Time	Method
the percent of cornea perforation	3 months

Trial Locations

Locations (1)

The First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, Guangdong, China