Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells
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
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 30, 2019
Detailed Description
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%
Interventions
- Biological: mesenchymal stem cells
- Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
- Biological: limbal stem cells
- Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
- Other: standard treatment
- Standard treatment according to the Clinical protocols
Arms, Groups and Cohorts
- Experimental: mesenchymal stem cells
- Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells
- Experimental: limbal stem cells
- Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells
- Active Comparator: control
- Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment
Clinical Trial Outcome Measures
Primary Measures
- Number of cured patients
- Time Frame: 2 month
- Number of patients cured
- Number of patients with treatment-related adverse events
- Time Frame: 4 weeks
- MSC/LSC application related adverse events assessed by blood count, liver and function tests
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Collaborator
- Belarusian State Medical University
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Igor Volotovski, Prof, Study Director, Head of the Lab of Institute of Biophysics and Cell Engineering
- Liudmila Marchenko, Prof, Study Director, Head of the Department of eyes diseases of Belarusian State Medical University
- Zinaida Kvacheva, Principal Investigator, Leading researcher, Institute of Biophysics and Cell Engineering
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