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Completed

NCT Number: NCT02325843

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • abnormal liver and renal function
  • the pregancy women -

Treatment and study plan

human bone marrow MSC

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of corneal perforation rate after subconjunctival injection of BMMSCs

    Time frame: 6 months

    the number of corneal perforation eyes/total eyes

  2. Time of corneal epithelialization

    Time frame: 6 month

    record the time when cornea finish epithelialization

  3. Visual acuity

    Time frame: 6 month

    Use the visual chart to record the decimal visual acuity

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

The Subconjunctival Injection of Human Bone Marrow Mesenchymal Stem Cells for Ocular Corneal Burn: Prospective, Case Series Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 25, 2014
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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