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Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Sponsor
Shaanxi Aierfu Activtissue Engineering (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01244776
Collaborator
Shenzhen AiNear Cornea Engineering Company Limited (Other), Air Force Military Medical University, China (Other), Engineering Technology Center for Tissue Engineering of Xi'an (Other), Beijing Tongren Hospital (Other), West China Hospital (Other), Henan Provincial People's Hospital (Other), Wuhan Union Hospital, China (Other), Southwest Hospital, China (Other)
100
Enrollment
1
Location
1
Arm
27
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.

Condition or Disease Intervention/Treatment Phase
  • Device: acellular corneal matrix
 N/A

Detailed Description

Infections, chemical injury, and other diseases result in acute or chronic corneal ulcer, which may damage corneal stroma and may lead to permanent corneal scars and blindness. Corneal transplantation is standard method for corneal ulcer, but severe shortage of donor corneas limits its application. Acellular porcine corneal matrix is similar to the native cornea, especially with the biological property and microstructure. Recently, this matrix has been proved to be safe when transplanted to animal subjects and will not be rejected by the recipient. In animal lamellar keratoplasty experiments, acellular corneal matrix showed that they can integrate into the corneal wound bed and help reconstruction of the lamellar integrity of corneal stroma. This study will investigate its healing effect on human corneal ulcer. It will provide a potential corneal substitute for this disease.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer
Study Start Date :
Apr 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acellular corneal matrix

Device: acellular corneal matrix
Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty.
Other Names:
  • ACM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rejection evaluation [30 days following transplantation]

    Secondary Outcome Measures

    1. Corneal wound healing [90 days following transplantation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients aged between 18 and 75 yrs.

    • Corneal ulcer.

    • Informed consent.

    Exclusion Criteria:

    • Corneal perforation.

    • Other ocular diseases.

    • The presence of systemic connective tissue diseases

    • Severe allergic constitution

    • Pregnancy

    • The presence of chronic disease, such as significant cardiovascular illness

    • The patients who received clinical experiments for other medicine or medical devices within 3 months prior to the transplantation.

    • Any patient that is not suitable for recruitment, in the judgment of the investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tongren Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Shaanxi Aierfu Activtissue Engineering
    • Shenzhen AiNear Cornea Engineering Company Limited
    • Air Force Military Medical University, China
    • Engineering Technology Center for Tissue Engineering of Xi'an
    • Beijing Tongren Hospital
    • West China Hospital
    • Henan Provincial People's Hospital
    • Wuhan Union Hospital, China
    • Southwest Hospital, China

    Investigators

    • Principal Investigator: Liuhe Zhou, M.D., Beijing Tongren Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01244776
    Other Study ID Numbers:
    • TEC 01
    First Posted:
    Nov 19, 2010
    Last Update Posted:
    May 6, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Corneal Ulcer
    Ulcer

    Study Results

    No Results Posted as of May 6, 2011