Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

May 5, 2011 updated by: Shaanxi Aierfu Activtissue Engineering
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:
          • Liuhe Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rejection evaluation
Time Frame: 30 days following transplantation
30 days following transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Corneal wound healing
Time Frame: 90 days following transplantation
90 days following transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaanxi Aierfu Activtissue Engineering

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

July 1, 2012

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (ESTIMATE)

November 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2011

Last Update Submitted That Met QC Criteria

May 5, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEC 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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