NCT05187104
Enrolling By Invitation
Phase 1
Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus1 site in 1 country20 target enrollmentMarch 1, 2022
ConditionsAge-Related Macular Degeneration
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Visual acuity
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Visual acuity
Time Frame: 1 year
Determination of visual acuity after the therapy
Adverse effects associated with the therapy
Time Frame: 1 year
Determination of adverse effects associated with the therapy
Study Sites (1)
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