the Treatment of Human Bone Marrow Mesenchymal Stem Cells in Ocular Corneal Burn
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02325843|
Recruitment Status : Not yet recruiting
First Posted : December 25, 2014
Last Update Posted : December 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chemical Burns||Other: human bone marrow MSC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Subconjunctival Injection of Human Bone Marrow Mesenchymal Stem Cells for Ocular Corneal Burn: Prospective,Double-blind, Randomized, Controlled Trial|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Active Comparator: human bone marrow MSC
human bone marrow MSC: 0.5ml （about 1 × 107 cells）subconjunctival injection every two weeks ,adiministered for 4 weeks,and combined with Amniotic Membrane Transplantation
Other: human bone marrow MSC
the arms of active comparator :human bone marrow MSC subconjunctival injection once per week,adminstered for 4 weeks
Placebo Comparator: fake subconjunctival injection
fake subconjunctival injection :0.5ml subconjunctival injection every two weeks ,adiministered for 4 weeks,and combined with Amniotic Membrane Transplantation
- the percent of cornea perforation [ Time Frame: 3 months ]keratoplasty must be performed immediately if the corneal perforation is about to happen
- the rate of Corneal epithelialization [ Time Frame: 6 months ]if the cornea fluorescein staining is negative,the corneal epithelium is regarded healled
- the area of corneal neovascularization [ Time Frame: 3 months ]grade Ⅰ: the area of corneal neovascularization is ≤30%； grade Ⅱ:the area of corneal neovascularization is ≤60%； grade Ⅲ:the area of corneal neovascularization is ＞60%；
- corneal opacity [ Time Frame: 3 months ]
- grade 0 is defined by No anterior segment structure visible.
- grade 1 is defined by Severe corneal haze, pupil not visible.
- grade 2 is defined by Corneal haze, iris details not seen, pupil visible.
- grade 3 is defined by Slight corneal haze, iris details seen.
- grade 4 is defined by Clear cornea.
- Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 3 months ]conjunctival ischemic;bleeding;allergy;
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
|Contact: Liang Dan, MDfirstname.lastname@example.org|
|Contact: Liang Lingyi, MDemail@example.com|
|Study Chair:||Liang Dan, MD||Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China|