Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease

Limbal Stem Cell Deficiency Clinical Trial

Official title:

Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03015779
• Other study ID #: 20161029
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: January 5, 2017
• Last updated: January 8, 2017
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: He Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Adminstration
• Study type: Interventional

Clinical Trial Summary

The aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.

Description:

A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain, pathological corneal epithelium regeneration, inflammation reaction and seriously visual loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells require immune suppressive medications, it can cause side effects in the body. Over the past 10 years, the clinical trials of application of cultured autologous oral mucosal epithelial cell sheet to treat LSCD have been emerged as a promising strategy in many countries. However, little study has been reported in China. This study investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease in China.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged>=18 years old

• Normal intraocular pressure

• Normal Eyelid

• No cataract and retinal disease

• No ulcers and tumor in the mouth

Exclusion Criteria:

• Severe Systemic infection

• History of acute phase of ocular and oral inflammation

• History of hyper sensibility or allergy to antibiotics or serum

• Women who are or may be pregnant

• Patients with infectious diseases

• Patients with other complications

Study Design

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

Related Conditions & MeSH terms

• Deficiency Diseases
• Limbal Stem Cell Deficiency

Intervention

Other:
• cultured autologous oral mucosal epithelial cell sheet
a prospective study,Before and after self control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The area of reepithelialization of corneal epithelium	The preoperative status of the eye will be recorded on the basis of clinical drawings and pre-and post-operative photographs. These pictures will be sent to two corneal experts in order to evaluate the results.; Judgement criterion: the results will be tested with a slit lamp: Normal: no epithelial loss; Mild: the area of epithelial loss <1/3; Moderate: the area of epithelial loss >1/3 <2/3; Severe: the area of epithelial loss> 2/3	3 months	No
Secondary	Improvement of best correct visual acuity		one year	No
Secondary	Decrease of corneal neovascularization		one year	No