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

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ClinicalTrials.gov Identifier: NCT02325843
Recruitment Status : Unknown
Verified December 2014 by Dan Liang, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : December 25, 2014
Last Update Posted : December 25, 2014
Sponsor:
Information provided by (Responsible Party):
Dan Liang, 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.

Condition or disease Intervention/treatment Phase
Chemical Burns Other: human bone marrow MSC Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. the percent of cornea perforation [ Time Frame: 3 months ]
    keratoplasty must be performed immediately if the corneal perforation is about to happen


Secondary Outcome Measures :
  1. the rate of Corneal epithelialization [ Time Frame: 6 months ]
    if the cornea fluorescein staining is negative,the corneal epithelium is regarded healled


Other Outcome Measures:
  1. 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%;

  2. corneal opacity [ Time Frame: 3 months ]
    1. grade 0 is defined by No anterior segment structure visible.
    2. grade 1 is defined by Severe corneal haze, pupil not visible.
    3. grade 2 is defined by Corneal haze, iris details not seen, pupil visible.
    4. grade 3 is defined by Slight corneal haze, iris details seen.
    5. grade 4 is defined by Clear cornea.

  3. Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 3 months ]
    conjunctival ischemic;bleeding;allergy;



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 six months -

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 -

Information from the National Library of Medicine

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


Contacts
Contact: Liang Dan, MD 0086-20-87331766 liangd2@mail.sysu.edu.cn
Contact: Liang Lingyi, MD 0086-20-87331537 lingyiliang@qq.com

Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Liang Dan, MD Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China