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

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 Overview

• Status: Unknown
• Conditions: Ocular Corneal Burn
• Intervention / Treatment: Biological: human umbilical cord mesenchymal stem cells; Biological: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Jinan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: group 1	Biological: human umbilical cord mesenchymal stem cells; human UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection
ACTIVE_COMPARATOR: group 2	Biological: placebo; Saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the percent of cornea perforation	3 months

Collaborators and Investigators

• Sponsor: Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): December 30, 2018
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: July 30, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (ACTUAL): August 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Eye Injuries; Burns; Eye Burns
• Other Study ID Numbers: SSCST-MSC-OCB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No