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

Study Overview
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Brief Summary
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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

Detailed Description
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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%

Official Title
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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

Conditions
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Corneal Ulcer, Corneal Disease, Corneal Dystrophy

Intervention / Treatment
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* Biological: mesenchymal stem cells
* Biological: limbal stem cells
* Other: standard treatment


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells | Biological: mesenchymal stem cells<br>* Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution<br>Other: standard treatment<br>* Standard treatment according to the Clinical protocols<br>|
| Experimental: limbal stem cells<br>Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells | Biological: limbal stem cells<br>* Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution<br>Other: standard treatment<br>* Standard treatment according to the Clinical protocols<br>|
| Active Comparator: control<br>Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment | Other: standard treatment<br>* Standard treatment according to the Clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cured patients | Number of patients cured | 2 month | 
| Number of patients with treatment-related adverse events | MSC/LSC application related adverse events assessed by blood count, liver and function tests | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal Disease