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Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

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ClinicalTrials.gov Identifier: NCT01244776
Recruitment Status : Unknown
Verified May 2011 by Shaanxi Aierfu Activtissue Engineering.
Recruitment status was:  Recruiting
First Posted : November 19, 2010
Last Update Posted : May 6, 2011
Sponsor:
Collaborators:
Information provided by:

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
Corneal Ulcer Device: acellular corneal matrix

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  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : April 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : July 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 Name: ACM


Outcome Measures

Primary Outcome Measures :
  1. Rejection evaluation [ Time Frame: 30 days following transplantation ]

Secondary Outcome Measures :
  1. Corneal wound healing [ Time Frame: 90 days following transplantation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01244776


Contacts
Contact: Yongbo Lu 86-29-84776153 yongerbo@gmail.com

Locations
China, Beijing
Beijing Tongren Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Liuhe Zhou         
Sponsors and Collaborators
Shaanxi Aierfu Activtissue Engineering
Shenzhen AiNear Cornea Engineering Company Limited
Fourth Military Medical University
Engineering Technology Center for Tissue Engineering of Xi'an
Beijing Tongren Hospital
West China Hospital
Henan Provincial Hospital
Wuhan Union Hospital, China
Southwest Hospital, China
Investigators
Principal Investigator: Liuhe Zhou, M.D. Beijing Tongren Hospital
More Information

Responsible Party: youngbo lu, Shaanxi Aierfu Activtissue Engineering
ClinicalTrials.gov Identifier: NCT01244776     History of Changes
Other Study ID Numbers: TEC 01
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Ulcer
Corneal Ulcer
Pathologic Processes
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases