Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells
NCT ID: NCT04484402
Last Updated: 2020-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2016-10-03
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mesenchymal stem cells
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells
mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
standard treatment
Standard treatment according to the Clinical protocols
limbal stem cells
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells
limbal stem cells
Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
standard treatment
Standard treatment according to the Clinical protocols
control
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment
standard treatment
Standard treatment according to the Clinical protocols
Interventions
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mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
limbal stem cells
Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
standard treatment
Standard treatment according to the Clinical protocols
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Belarusian State Medical University
OTHER
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
OTHER_GOV
Responsible Party
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Principal Investigators
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Igor Volotovski, Prof
Role: STUDY_DIRECTOR
Head of the Lab of Institute of Biophysics and Cell Engineering
Liudmila Marchenko, Prof
Role: STUDY_DIRECTOR
Head of the Department of eyes diseases of Belarusian State Medical University
Zinaida Kvacheva
Role: PRINCIPAL_INVESTIGATOR
Leading researcher, Institute of Biophysics and Cell Engineering
Locations
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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, , Belarus
Countries
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Other Identifiers
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IBCE_LSC
Identifier Type: -
Identifier Source: org_study_id
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