Age-Related Macular DegenerationPhase 1/2NCT05187104
Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
A Phase 1/2 study testing Cultured retinal stem and progenitor cells and Standard treatment according to the clinical protocols in people with Age-Related Macular Degeneration, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of age-related macular degeneration using retinal stem and progenitor cells Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Cultured retinal stem and progenitor cells and Standard treatment according to the clinical protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Mar 2022to 31 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of age-related macular degeneration
- The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- Written informed consent
Who cannot join
- The presence of any malignant tumor within the last 5 years
- Acute or chronic diseases in the stage of decompensation
- Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
- Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
- Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
- Patients are unable or unwilling to give written informed consent and / or follow research procedures
- Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
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
Treatment of age-related macular degeneration using retinal stem and progenitor cells
Read the detailed description
The aim of the project is to develop a biomedical cell product based on retinal pigment epithelium cells for highly effective treatment age-related macular degeneration; to conduct the clinical trials of the biomedical cell product in the treatment of age-related macular degeneration.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Cultured retinal stem and progenitor cells, Standard treatment according to the clinical protocols
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultured retinal stem and progenitor cellsBiological
Cultured retinal stem and progenitor cells injected subretinally
Standard treatment according to the clinical protocolsOther
Standard treatment of age-related macular degeneration according to the clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| Patients with age-related macular degeneration receiving standard treatment and retinal stem cells | Experimental | Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells Receives: Biological: Cultured retinal stem and progenitor cells; Other: Standard treatment according to the clinical protocols |
| Patients with age-related macular degeneration receiving standard treatment | Active comparator | Patients with age-related macular degeneration receiving standard treatment Receives: Other: Standard treatment according to the clinical protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Determination of visual acuity after the therapy
Measured: 1 month
Visual acuity
Determination of visual acuity after the therapy
Measured: 1 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 month
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- 20 participants (estimated)
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
- Ludmila Marchenko, Prof, Study director, Belarusian State Medical UniversityZinaida Kvacheva, Dr, Study director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187104
- Sponsor's protocol ID
- IBCE_Retinal
- Status last verified
- Sep 2022
- First submitted
- 24 Dec 2021
- Last updated
- 14 Sep 2022
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
- ClinicalTrials.gov ID
- NCT05187104
- Acronym / sponsor ID
- IBCE_Retinal
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Jan 2022 (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 age-related macular degeneration using retinal stem and progenitor cells
Detailed description
The aim of the project is to develop a biomedical cell product based on retinal pigment epithelium cells for highly effective treatment age-related macular degeneration; to conduct the clinical trials of the biomedical cell product in the treatment of age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with age-related macular degeneration receiving standard treatment and retinal stem cells | Experimental | Biological: Cultured retinal stem and progenitor cells, Other: Standard treatment according to the clinical protocolsPatients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells |
| Patients with age-related macular degeneration receiving standard treatment | Active comparator | Other: Standard treatment according to the clinical protocolsPatients with age-related macular degeneration receiving standard treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of age-related macular degeneration
- The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- Written informed consent
Key exclusion criteria (7 listed)
- The presence of any malignant tumor within the last 5 years
- Acute or chronic diseases in the stage of decompensation
- Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
- Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
- Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
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 |
|---|---|---|
| Cultured retinal stem and progenitor cellsCultured retinal stem and progenitor cells injected subretinally | Biological | Patients with age-related macular degeneration receiving standard treatment and retinal stem cells |
| Standard treatment according to the clinical protocolsStandard treatment of age-related macular degeneration according to the clinical protocols | Other | Patients with age-related macular degeneration receiving standard treatment, Patients with age-related macular degeneration receiving standard treatment and retinal stem cells |
Primary outcome
Visual acuity
Time frame: 1 month
Determination of visual acuity after the therapy
Visual acuity
Time frame: 1 year
Determination of visual acuity after the therapy
Adverse effects associated with the therapy
Time frame: 1 month
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Time frame: 1 year
Determination of adverse effects associated with the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- 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.
Ludmila Marchenko, Prof study director
Belarusian State Medical University
Zinaida Kvacheva, Dr study director
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
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 Cultured retinal stem and progenitor cells and Standard treatment according to the clinical protocols in people with Age-Related Macular Degeneration, 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. 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?
Results are not available in the source record.
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?
Visual acuity (time frame: 1 month). The study lists 4 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 14 Sep 2022.