Clinical trial NCT02325843: the Treatment of Human Bone Marrow Mesenchymal Stem Cells in Ocular Corneal Burn
Official title: The Subconjunctival Injection of Human Bone Marrow Mesenchymal Stem Cells for Ocular Corneal Burn: Prospective, Case Series Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemical Burns
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 -

Primary outcomes:
measure: Incidence of adverse events by subconjunctival injection of BMMSCs
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of corneal perforation rate after subconjunctival injection of BMMSCs
timeFrame: 6 months
measure: Time of corneal epithelialization
timeFrame: 6 month
measure: Visual acuity
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China
name: Liang Dan, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: Hargraves MM. Discovery of the LE cell and its morphology. Mayo Clin Proc. 1969 Sep;44(9):579-99. No abstract available.