Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Corneal Ulcer Clinical Trial

Official title:

Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01244776
• Other study ID #: TEC 01
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2010
• Last updated: May 5, 2011
• Start date: April 2010
• Est. completion date: July 2012

Study information

• Verified date: May 2011
• Source: Shaanxi Aierfu Activtissue Engineering
• Contact: Yongbo Lu
• Phone: 86-29-84776153
• Email: yongerbo[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (9)

Lead Sponsor	Collaborator
Shaanxi Aierfu Activtissue Engineering	Beijing Tongren Hospital, Engineering Technology Center for Tissue Engineering of Xi'an, Fourth Military Medical University, Henan Provincial Hospital, Shenzhen AiNear Cornea Engineering Company Limited, Southwest Hospital, China, West China Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rejection evaluation		30 days following transplantation	Yes
Secondary	Corneal wound healing		90 days following transplantation	No