- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187104
Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
September 9, 2022 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Treatment of age-related macular degeneration using retinal stem and progenitor cells
Study Overview
Status
Enrolling by invitation
Conditions
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Minsk, Belarus, 220072
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with age-related macular degeneration receiving standard treatment and retinal stem cells
Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells
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Cultured retinal stem and progenitor cells injected subretinally
Standard treatment of age-related macular degeneration according to the clinical protocols
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Active Comparator: Patients with age-related macular degeneration receiving standard treatment
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Standard treatment of age-related macular degeneration according to the clinical protocols
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: 1 month
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Determination of visual acuity after the therapy
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1 month
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Visual acuity
Time Frame: 1 year
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Determination of visual acuity after the therapy
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1 year
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Adverse effects associated with the therapy
Time Frame: 1 month
|
Determination of adverse effects associated with the therapy
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1 month
|
Adverse effects associated with the therapy
Time Frame: 1 year
|
Determination of adverse effects associated with the therapy
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Ludmila Marchenko, Prof, Belarusian State Medical University
- Study Director: Zinaida Kvacheva, Dr, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
December 24, 2021
First Submitted That Met QC Criteria
December 24, 2021
First Posted (Actual)
January 11, 2022
Study Record Updates
Last Update Posted (Actual)
September 14, 2022
Last Update Submitted That Met QC Criteria
September 9, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBCE_Retinal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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