Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Corneal disease is a leading cause of blindness in the world. A shortage of corneal donor tissue has prevented many patients from regaining vision. Additionally, refractive error such as myopia is a major cause of impaired visual function worldwide. Although refractive error is correctable by procedures that modify the refractive power of the cornea, these procedures often weaken corneal integrity and have risk of complications. This study aims to evaluate the safety and efficacy of corneal surface epithelium repair and regeneration in the treatment of corneal surface diseases and refractive error using autologous limbal stem cell transplantation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Levofloxacin; Ofloxacin; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Monocular corneal chemical injury or pterygium, or refractive error greater than +/- 2D

• Informed consent signed by patient or legal guardian

Exclusion Criteria:

• Patients with a history of corneal perforation or surgery

• Patients with other eye diseases

• Patients with a history of severe cardiovascular, liver, kidney, endocrine, and hematopoietic disease, diabetes, or immune deficiency disorders

• Pregnant or lactating women

• Patients who are participating in other clinical trials

• Patients with a history of mental illness who are unable to give informed consent or follow up according to the study protocol.