the Treatment of Human Bone Marrow Mesenchymal Stem Cells in Ocular Corneal Burn
Primary Purpose
Chemical Burns
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
human bone marrow MSC
Sponsored by
About this trial
This is an interventional treatment trial for Chemical Burns
Eligibility Criteria
Inclusion Criteria:
- must be ocular burns including chemically burned or the thermally burned
- the severity degree should above the Ⅳ degree,including the Ⅳ degree(according the classification of Dua standard,2001)
- 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.
- the incident time should be within 2 weeks -
Exclusion Criteria:
- the visual acuity is blind in any of the eye
- have corneal perforation or have the corneal perforation tendency
- have been accepted surgury on eyeball after trauma
- IOP≥25mmHg even after antiglaucoma
- have the history of other corneal diseaze or surgury
- have the history of radiotherapy or surgury in the eyeball
- associated with corneal ulcer or endoophthalmitis
- uncontrolled hypertension(≥150/95mmHg)
- abnormal liver and renal function
- the pregancy women -
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
human bone marrow MSC
Arm Description
5×106/0.5ml MSC was injected subconjunctival at the inferior fornix.If persistent epithelial defect was noted thereafter, a second AMT and MSC injection was performed.
Outcomes
Primary Outcome Measures
Incidence of adverse events by subconjunctival injection of BMMSCs
Record the adverse events, including topical complications such as ocular infection, conjunctival necrosis at the injection site, retinal artery occlusion, and systemic complications such as fever, urticaria, hemolysis, hypotension, renal and liver dysfunction, tumor formation, and/or abnormalities in complete blood counts.
Secondary Outcome Measures
Incidence of corneal perforation rate after subconjunctival injection of BMMSCs
the number of corneal perforation eyes/total eyes
Time of corneal epithelialization
record the time when cornea finish epithelialization
Visual acuity
Use the visual chart to record the decimal visual acuity
Full Information
NCT ID
NCT02325843
First Posted
December 10, 2014
Last Updated
April 9, 2019
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02325843
Brief Title
the Treatment of Human Bone Marrow Mesenchymal Stem Cells in Ocular Corneal Burn
Official Title
The Subconjunctival Injection of Human Bone Marrow Mesenchymal Stem Cells for Ocular Corneal Burn: Prospective, Case Series Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ocular chemical burn is one of the cause of vision loss in our country, and there are no satisfactory treatment. Human bone marrow mesenchymal stem cells (MSC) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of mesenchymal stem cell in the treatment of corneal burn in human.
Detailed Description
Corneal burn is a ocular damage disease included chemically burned and thermally burned. Surgery of corneal transplantation,amniotic membrane transplantation are some of effective,however,these therapy are expensive and the transplantation resources are limited. To arrest the inflammatory phase, several types of immunosuppressive treatments have been investigated. Corticosteroids also is important, however, long time usage of corticosteroids often cause severe side-effects. Human bone marrow mesenchymal stem cells (MSC) have the biological characteristics of self -renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC can accelerated the cornea repair, inhibited angiogenesis. Many animal research also revealed that MSC have effect on the ocular alkali burned. And subconjunctivity injection is efficient, the clinical study of MSC on treating other disease have been developed rapidly recently, in further ,the outcome are encouraging, and no side-effect related MSC was reported, MSC can come from bone marrow, Umbilical cord blood,Adipose tissue and so on, but bone marrow MSC is mostly common used. The investigators propose to assess the efficacy and safety of human bone marrow mesenchymal stem cell 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
Chemical Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
human bone marrow MSC
Arm Type
Experimental
Arm Description
5×106/0.5ml MSC was injected subconjunctival at the inferior fornix.If persistent epithelial defect was noted thereafter, a second AMT and MSC injection was performed.
Intervention Type
Other
Intervention Name(s)
human bone marrow MSC
Intervention Description
The arms of active comparator :human bone marrow MSC subconjunctival injection once time. If persistent epithelial defect was noted thereafter, a second MSC injection was performed.
Primary Outcome Measure Information:
Title
Incidence of adverse events by subconjunctival injection of BMMSCs
Description
Record the adverse events, including topical complications such as ocular infection, conjunctival necrosis at the injection site, retinal artery occlusion, and systemic complications such as fever, urticaria, hemolysis, hypotension, renal and liver dysfunction, tumor formation, and/or abnormalities in complete blood counts.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of corneal perforation rate after subconjunctival injection of BMMSCs
Description
the number of corneal perforation eyes/total eyes
Time Frame
6 months
Title
Time of corneal epithelialization
Description
record the time when cornea finish epithelialization
Time Frame
6 month
Title
Visual acuity
Description
Use the visual chart to record the decimal visual acuity
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must be ocular burns including chemically burned or the thermally burned
the severity degree should above the Ⅳ degree,including the Ⅳ degree(according the classification of Dua standard,2001)
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.
the incident time should be within 2 weeks -
Exclusion Criteria:
the visual acuity is blind in any of the eye
have corneal perforation or have the corneal perforation tendency
have been accepted surgury on eyeball after trauma
IOP≥25mmHg even after antiglaucoma
have the history of other corneal diseaze or surgury
have the history of radiotherapy or surgury in the eyeball
associated with corneal ulcer or endoophthalmitis
uncontrolled hypertension(≥150/95mmHg)
abnormal liver and renal function
the pregancy women -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Dan, MD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
22531326
Citation
Le Blanc K, Mougiakakos D. Multipotent mesenchymal stromal cells and the innate immune system. Nat Rev Immunol. 2012 Apr 25;12(5):383-96. doi: 10.1038/nri3209.
Results Reference
background
PubMed Identifier
3706914
Citation
Gao XH, Roberts A. The left triangular ligament of the liver and the structures in its free edge (appendix fibrosa hepatis) in Chinese and Canadian cadavers. Am Surg. 1986 May;52(5):246-52.
Results Reference
background
PubMed Identifier
4186059
Citation
Hargraves MM. Discovery of the LE cell and its morphology. Mayo Clin Proc. 1969 Sep;44(9):579-99. No abstract available.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22531326
Description
Multipotent mesenchymal stromal cells and the innate immune system
URL
http://www.ncbi.nlm.nih.gov/pubmed/23742637
Description
Immunoregulatory properties of clinical grade mesenchymal stromal cells: evidence, uncertainties, and clinical application
URL
http://www.ncbi.nlm.nih.gov/pubmed/24849741
Description
Modulation of the Early Inflammatory Microenvironment in the Alkali-Burned Eye by Systemically Administered Interferon-gamma-Treated Mesenchymal Stromal Cells
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the Treatment of Human Bone Marrow Mesenchymal Stem Cells in Ocular Corneal Burn
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