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

NCT ID: NCT02325843

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Chemical Burns

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

human bone marrow MSC

Intervention Type: 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.

Interventions

human bone marrow MSC

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.

Intervention Type: OTHER

Eligibility 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 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Dan Liang

M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang Dan, MD

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China

References

Le Blanc K, Mougiakakos D. Multipotent mesenchymal stromal cells and the innate immune system. Nat Rev Immunol. 2012 Apr 25;12(5):383-96. doi: 10.1038/nri3209.

Reference Type: BACKGROUND

PMID: 22531326 (View on PubMed)

Gao XH, Roberts A. The left triangular ligament of the liver and the structures in its free edge (appendix fibrosa hepatis) in Chinese and Canadian cadavers. Am Surg. 1986 May;52(5):246-52.

Reference Type: BACKGROUND

PMID: 3706914 (View on PubMed)

Hargraves MM. Discovery of the LE cell and its morphology. Mayo Clin Proc. 1969 Sep;44(9):579-99. No abstract available.

Reference Type: RESULT

PMID: 4186059 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/22531326

Multipotent mesenchymal stromal cells and the innate immune system

http://www.ncbi.nlm.nih.gov/pubmed/23742637

Immunoregulatory properties of clinical grade mesenchymal stromal cells: evidence, uncertainties, and clinical application

http://www.ncbi.nlm.nih.gov/pubmed/24849741

Modulation of the Early Inflammatory Microenvironment in the Alkali-Burned Eye by Systemically Administered Interferon-gamma-Treated Mesenchymal Stromal Cells

Other Identifiers

2014MEKY059

Identifier Type: -

Identifier Source: org_study_id