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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| human bone marrow MSC | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human bone marrow MSC | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of corneal perforation rate after subconjunctival injection of BMMSCs | the number of corneal perforation eyes/total eyes | 6 months |
| Time of corneal epithelialization | record the time when cornea finish epithelialization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liang Dan, MD | Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22531326 | Background | 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. | |
| 3706914 | Background | 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. |
| Label | URL |
|---|---|
| Multipotent mesenchymal stromal cells and the innate immune system | View source |
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| ID | Term |
|---|---|
| D002057 | Burns, Chemical |
| ID | Term |
|---|---|
| D002056 | Burns |
| D014947 | Wounds and Injuries |
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| 6 month |
| Visual acuity | Use the visual chart to record the decimal visual acuity | 6 month |
| 4186059 | Result | Hargraves MM. Discovery of the LE cell and its morphology. Mayo Clin Proc. 1969 Sep;44(9):579-99. No abstract available. |
| Immunoregulatory properties of clinical grade mesenchymal stromal cells: evidence, uncertainties, and clinical application | View source |
| Modulation of the Early Inflammatory Microenvironment in the Alkali-Burned Eye by Systemically Administered Interferon-gamma-Treated Mesenchymal Stromal Cells | View source |