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

He Eye Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Limbal Stem Cell Deficiency

Treatments: Other: cultured autologous oral mucosal epithelial cell sheet

Study type: Interventional

Funder types: Other

Identifiers

NCT03015779

20161029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

experimental group

Experimental group

Description:

cultured autologous oral mucosal epithelial cell sheet

Treatment:

Other: cultured autologous oral mucosal epithelial cell sheet