Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

Ocular Corneal Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03237442
• Other study ID #: SSCST-MSC-OCB-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 30, 2017
• Last updated: August 1, 2017
• Start date: January 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2017
• Source: Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.
• Contact: Wanling Chen
• Phone: 0086-20-37792600
• Email: chenwanling[@]saliai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Eye Burns
• Ocular Corneal Burn

Intervention

Biological:
• human umbilical cord mesenchymal stem cells
human UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection
• placebo
Saline injection

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percent of cornea perforation		3 months