Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells
1 other identifier
interventional
25
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedFirst Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedJuly 30, 2020
July 1, 2020
3.2 years
July 20, 2020
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
mesenchymal stem cells
EXPERIMENTALPatients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells
limbal stem cells
EXPERIMENTALPatients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells
control
ACTIVE COMPARATORPatients with inflammatory-dystrophic diseases of the cornea receiving standard treatment
Interventions
Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
Standard treatment according to the Clinical protocols
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072, Belarus
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Igor Volotovski, Prof
Head of the Lab of Institute of Biophysics and Cell Engineering
- STUDY DIRECTOR
Liudmila Marchenko, Prof
Head of the Department of eyes diseases of Belarusian State Medical University
- PRINCIPAL INVESTIGATOR
Zinaida Kvacheva
Leading researcher, Institute of Biophysics and Cell Engineering
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2020
First Posted
July 23, 2020
Study Start
October 3, 2016
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
July 30, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share