Clinical Trial: the Treatment of Human Bone Marrow Mesenchymal Stem Cells in Ocular Corneal Burn

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Subconjunctival Injection of Human Bone Marrow Mesenchymal Stem Cells for Ocular Corneal Burn: Prospective,Double-blind, Randomized, Controlled Trial

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 Summary: 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.
Sponsor: Sun Yat-sen University

Current Primary Outcome: the percent of cornea perforation [ Time Frame: 3 months ]

keratoplasty must be performed immediately if the corneal perforation is about to happen


Original Primary Outcome: Same as current

Current Secondary Outcome: the rate of Corneal epithelialization [ Time Frame: 6 months ]

if the cornea fluorescein staining is negative,the corneal epithelium is regarded healled


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: December 10, 2014
Date Started: July 2015
Date Completion: November 2018
Last Updated: December 20, 2014
Last Verified: December 2014