human bone marrow MSC
OtherThe 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.
NCT Number: NCT02325843
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
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
the number of corneal perforation eyes/total eyes
Time frame: 6 month
record the time when cornea finish epithelialization
Time frame: 6 month
Use the visual chart to record the decimal visual acuity
Sun Yat-sen University
Other
The Subconjunctival Injection of Human Bone Marrow Mesenchymal Stem Cells for Ocular Corneal Burn: Prospective, Case Series Study
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