Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus25 enrolled

Overview

Treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous limbal stem cells (corneal epithelial stem cells) or adipose-derived mesenchymal stem cells

In order to treat inflammatory and dystrophic diseases of the cornea perilimbal injections of cultured autologous stem cells are performed. Corneal (limbal) epithelial stem cells (LSC) or mesenchymal stem cells derived from adipose tissue (ADSC) are mixed with sodium hyaluronate 1%

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Corneal Ulcer Corneal Disease Corneal Dystrophy

Interventions

mesenchymal stem cellsBIOLOGICAL

Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution

limbal stem cellsBIOLOGICAL

Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution

standard treatmentOTHER

Standard treatment according to the Clinical protocols

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * inflammatory-dystrophic diseases of the cornea: 1. Epithelial defects of the cornea, ulcerative keratitis of various etiology, resistant to standard methods of treatment 2. Dystrophic diseases of the cornea, accompanied by edema 3. Burns of the cornea 4. Neurotrophic forms of keratitis 5. Persistent post-traumatic, postoperative, contusion keratitis and keratopathy Exclusion Criteria: 1. Pregnancy. 2. Viral hepatitis B and C, HIV, tubeculosis and other chronic viral and bacterial infections. 3. Cancer or leukemia 4. Any diseases in the stage of decompensation. 5. Mental disorders. 6. Anomalies of eye refraction

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, Belarus

Outcomes

Primary Outcomes

Number of cured patients

Number of patients cured

Time frame: 2 month

Number of patients with treatment-related adverse events

MSC/LSC application related adverse events assessed by blood count, liver and function tests

Time frame: 4 weeks

Data from ClinicalTrials.gov

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