Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Shaanxi Aierfu Activtissue Engineering.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
Information provided by:
Shaanxi Aierfu Activtissue Engineering
ClinicalTrials.gov Identifier:
NCT01244776
First received: November 18, 2010
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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 Intervention
Corneal Ulcer
Device: acellular corneal matrix

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Resource links provided by NLM:


Further study details as provided by Shaanxi Aierfu Activtissue Engineering:

Primary Outcome Measures:
  • Rejection evaluation [ Time Frame: 30 days following transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Corneal wound healing [ Time Frame: 90 days following transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: youngbo lu, Shaanxi Aierfu Activtissue Engineering
ClinicalTrials.gov Identifier: NCT01244776     History of Changes
Other Study ID Numbers: TEC 01
Study First Received: November 18, 2010
Last Updated: May 5, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014