Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells

Study Overview
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Brief Summary
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Treatment of age-related macular degeneration using retinal stem and progenitor cells

Detailed Description
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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.

Official Title
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Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Biological: Cultured retinal stem and progenitor cells
* Other: Standard treatment according to the clinical protocols


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention 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<br>Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells | Biological: Cultured retinal stem and progenitor cells<br>* Cultured retinal stem and progenitor cells injected subretinally<br>Other: Standard treatment according to the clinical protocols<br>* Standard treatment of age-related macular degeneration according to the clinical protocols<br>|
| Active Comparator: Patients with age-related macular degeneration receiving standard treatment<br>Patients with age-related macular degeneration receiving standard treatment | Other: Standard treatment according to the clinical protocols<br>* Standard treatment of age-related macular degeneration according to the clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Determination of visual acuity after the therapy | 1 month | 
| Visual acuity | Determination of visual acuity after the therapy | 1 year | 
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 month | 
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 year |