Age-Related Macular Degeneration
Conditions
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.
Interventions
BIOLOGICALCultured retinal stem and progenitor cells
Cultured retinal stem and progenitor cells injected subretinally
Standard treatment of age-related macular degeneration according to the clinical protocols
Sponsors
Belarusian State Medical University
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 1 month | Determination of visual acuity after the therapy |
| Adverse effects associated with the therapy | 1 month | Determination of adverse effects associated with the therapy |
Countries
Belarus
Outcome results
None listed