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

NCT02325843 | Completed Phase 2

• 1 other identifier: 2014MEKY059
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chemical Burns

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events by subconjunctival injection of BMMSCs

  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.

  6 months

Secondary Outcomes (3)

• Incidence of corneal perforation rate after subconjunctival injection of BMMSCs

  6 months

• Time of corneal epithelialization

  6 month

• Visual acuity

  6 month

Study Arms (1)

human bone marrow MSC

EXPERIMENTAL

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.

Other: human bone marrow MSC

Interventions

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.

human bone marrow MSC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Sun Yat-sen University: lead

Related Publications (3)

• 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.

  PMID: 22531326 BACKGROUND

• 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.

  PMID: 3706914 BACKGROUND

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

  PMID: 4186059 RESULT

Related Links

• Multipotent mesenchymal stromal cells and the innate immune system
• Immunoregulatory properties of clinical grade mesenchymal stromal cells: evidence, uncertainties, and clinical application
• Modulation of the Early Inflammatory Microenvironment in the Alkali-Burned Eye by Systemically Administered Interferon-gamma-Treated Mesenchymal Stromal Cells

MeSH Terms

Conditions

Burns, Chemical

Condition Hierarchy (Ancestors)

Burns; Wounds and Injuries

Study Officials

• Liang Dan, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 25, 2014
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 11, 2019

Record last verified: 2019-04