the Treatment of Human Bone Marrow Mesenchymal Stem Cells in Ocular Corneal Burn
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|ClinicalTrials.gov Identifier: NCT02325843|
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chemical Burns||Other: human bone marrow MSC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Subconjunctival Injection of Human Bone Marrow Mesenchymal Stem Cells for Ocular Corneal Burn: Prospective, Case Series Study|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: human bone marrow MSC
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.
Other: human bone marrow MSC
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.
- Incidence of adverse events by subconjunctival injection of BMMSCs [ 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.
- Incidence of corneal perforation rate after subconjunctival injection of BMMSCs [ Time Frame: 6 months ]the number of corneal perforation eyes/total eyes
- Time of corneal epithelialization [ Time Frame: 6 month ]record the time when cornea finish epithelialization
- Visual acuity [ Time Frame: 6 month ]Use the visual chart to record the decimal visual acuity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325843
|Study Chair:||Liang Dan, MD||Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China|