CompletedPhase 2

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

16 participantsStarted 2015-07

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. the visual acuity is blind in any of the eye
✕. have corneal perforation or have the corneal perforation tendency
✕. have been accepted surgury on eyeball after trauma
✕. IOP≥25mmHg even after antiglaucoma
✕. have the history of other corneal diseaze or surgury
✕. have the history of radiotherapy or surgury in the eyeball
✕. associated with corneal ulcer or endoophthalmitis
✕. uncontrolled hypertension(≥150/95mmHg)

What they're measuring

Incidence of adverse events by subconjunctival injection of BMMSCs

Timeframe: 6 months

Trial details

NCT IDNCT02325843

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

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