Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
Study Details
Study Description
Brief Summary
Treatment of age-related macular degeneration using retinal stem and progenitor cells
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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
Arms and Interventions
| 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 |
Biological: Cultured retinal stem and progenitor cells
Cultured retinal stem and progenitor cells injected subretinally
Other: Standard treatment according to the clinical protocols
Standard treatment of age-related macular degeneration according to the clinical protocols
|
| Active Comparator: Patients with age-related macular degeneration receiving standard treatment Patients with age-related macular degeneration receiving standard treatment |
Other: Standard treatment according to the clinical protocols
Standard treatment of age-related macular degeneration according to the clinical protocols
|
Outcome Measures
Primary Outcome Measures
- Visual acuity [1 month]
Determination of visual acuity after the therapy
- Visual acuity [1 year]
Determination of visual acuity after the therapy
- Adverse effects associated with the therapy [1 month]
Determination of adverse effects associated with the therapy
- Adverse effects associated with the therapy [1 year]
Determination of adverse effects associated with the therapy
Eligibility Criteria
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
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Belarusian State Medical University
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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- IBCE_Retinal