Back to resultsUmbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
Primary Purpose
Ocular Corneal Burn
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human umbilical cord mesenchymal stem cells
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Corneal Burn
Eligibility 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.
Sites / Locations
- The First Affiliated Hospital of Jinan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group 1
group 2
Arm Description
Outcomes
Primary Outcome Measures
the percent of cornea perforation
Secondary Outcome Measures
Full Information
NCT ID
NCT03237442
First Posted
July 30, 2017
Last Updated
August 1, 2017
Sponsor
Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03237442
Brief Title
Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
Official Title
Placebo-Controlled,Randomized,Double-blind Trial of Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Corneal Burn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Title
group 2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
human umbilical cord mesenchymal stem cells
Intervention Description
human UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
Saline injection
Primary Outcome Measure Information:
Title
the percent of cornea perforation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanling Chen
Phone
0086-20-37792600
Email
chenwanling@saliai.com
Facility Information:
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Ma
12. IPD Sharing Statement
Learn more about this trial
Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
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