Corneal UlcerPhase 1/2NCT04484402
Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells
A Phase 1/2 study testing mesenchymal stem cells, limbal stem cells and standard treatment in people with Corneal Ulcer and Corneal Disease, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Ulcer, Corneal Disease, Corneal Dystrophy
- What is being tested?
- mesenchymal stem cells, limbal stem cells and standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelarus
- Study dates
- 3 Oct 2016to 30 Dec 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
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
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
Read the 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%
- Conditions
- Corneal Ulcer, Corneal Disease, Corneal Dystrophy
- Being tested
- mesenchymal stem cells, limbal stem cells, standard treatment
- Keywords
- Corneal Disease
- Medical subject headings
- Corneal Ulcer, Corneal Diseases, Corneal Dystrophies, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellsBiological
Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
limbal stem cellsBiological
Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
standard treatmentOther
Standard treatment according to the Clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells Receives: Biological: mesenchymal stem cells; Other: standard treatment |
| limbal stem cells | Experimental | Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells Receives: Biological: limbal stem cells; Other: standard treatment |
| control | Active comparator | Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cured patients
Number of patients cured
Measured: 2 month
Number of patients with treatment-related adverse events
MSC/LSC application related adverse events assessed by blood count, liver and function tests
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start3 Oct 2016
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian State Medical University
- Responsible party
- Sponsor
- Investigators
- Igor Volotovski, Prof, Study director, Head of the Lab of Institute of Biophysics and Cell EngineeringLiudmila Marchenko, Prof, Study director, Head of the Department of eyes diseases of Belarusian State Medical UniversityZinaida Kvacheva, Principal investigator, Leading researcher, Institute of Biophysics and Cell Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484402
- Sponsor's protocol ID
- IBCE_LSC
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04484402
- Acronym / sponsor ID
- IBCE_LSC
- Conditions
- Corneal Ulcer, Corneal Disease, Corneal Dystrophy
- Keywords
- Corneal Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian State Medical University
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: mesenchymal stem cells, Other: standard treatmentPatients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells |
| limbal stem cells | Experimental | Biological: limbal stem cells, Other: standard treatmentPatients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells |
| control | Active comparator | Other: standard treatmentPatients with inflammatory-dystrophic diseases of the cornea receiving standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- inflammatory-dystrophic diseases of the cornea:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesenchymal stem cellsAutologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution | Biological | mesenchymal stem cells |
| limbal stem cellsAutologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution | Biological | limbal stem cells |
| standard treatmentStandard treatment according to the Clinical protocols | Other | control, limbal stem cells, mesenchymal stem cells |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mesenchymal stem cells, limbal stem cells and standard treatment in people with Corneal Ulcer and Corneal Disease, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cured patients (time frame: 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.