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

Phase 2

Completed

• Conditions: Chemical Burns
• Interventions: Other: human bone marrow MSC

• Registration Number: NCT02325843
• Lead Sponsor: Sun Yat-sen University

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 Description

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.

Study Timeline

• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-20
• Study First Posted: 2014-12-25
• Study Start: 2015-07
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. must be ocular burns including chemically burned or the thermally burned
2. the severity degree should above the Ⅳ degree,including the Ⅳ degree(according the classification of Dua standard,2001)
3. the subjects are willing to accept this research,and promise to coordinate with the researchers during the follow up period
4. the subjects should abide by the laws and rules of the study.
5. the incident time should be within 2 weeks -

Exclusion Criteria

1. the visual acuity is blind in any of the eye
2. have corneal perforation or have the corneal perforation tendency
3. have been accepted surgury on eyeball after trauma
4. IOP≥25mmHg even after antiglaucoma
5. have the history of other corneal diseaze or surgury
6. have the history of radiotherapy or surgury in the eyeball
7. associated with corneal ulcer or endoophthalmitis
8. uncontrolled hypertension(≥150/95mmHg)
9. abnormal liver and renal function
10. the pregancy women -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
human bone marrow MSC	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.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events by subconjunctival injection of BMMSCs	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of corneal perforation rate after subconjunctival injection of BMMSCs	6 months	the number of corneal perforation eyes/total eyes
Time of corneal epithelialization	6 month	record the time when cornea finish epithelialization
Visual acuity	6 month	Use the visual chart to record the decimal visual acuity