Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells
Primary Purpose
Corneal Ulcer, Corneal Disease, Corneal Dystrophy
Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
mesenchymal stem cells
limbal stem cells
standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Ulcer focused on measuring Corneal Disease
Eligibility Criteria
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
Sites / Locations
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
mesenchymal stem cells
limbal stem cells
control
Arm Description
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment
Outcomes
Primary Outcome Measures
Number of cured patients
Number of patients cured
Number of patients with treatment-related adverse events
MSC/LSC application related adverse events assessed by blood count, liver and function tests
Secondary Outcome Measures
Full Information
NCT ID
NCT04484402
First Posted
July 20, 2020
Last Updated
July 28, 2020
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04484402
Brief Title
Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells
Official Title
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
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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%
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Ulcer, Corneal Disease, Corneal Dystrophy
Keywords
Corneal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mesenchymal stem cells
Arm Type
Experimental
Arm Description
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells
Arm Title
limbal stem cells
Arm Type
Experimental
Arm Description
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells
Arm Title
control
Arm Type
Active Comparator
Arm Description
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment
Intervention Type
Biological
Intervention Name(s)
mesenchymal stem cells
Intervention Description
Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
Intervention Type
Biological
Intervention Name(s)
limbal stem cells
Intervention Description
Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
Intervention Type
Other
Intervention Name(s)
standard treatment
Intervention Description
Standard treatment according to the Clinical protocols
Primary Outcome Measure Information:
Title
Number of cured patients
Description
Number of patients cured
Time Frame
2 month
Title
Number of patients with treatment-related adverse events
Description
MSC/LSC application related adverse events assessed by blood count, liver and function tests
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Volotovski, Prof
Organizational Affiliation
Head of the Lab of Institute of Biophysics and Cell Engineering
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Liudmila Marchenko, Prof
Organizational Affiliation
Head of the Department of eyes diseases of Belarusian State Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zinaida Kvacheva
Organizational Affiliation
Leading researcher, Institute of Biophysics and Cell Engineering
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells
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