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

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Age-Related Macular Degeneration

Treatments: Biological: Cultured retinal stem and progenitor cells; Other: Standard treatment according to the clinical protocols

Study type: Interventional

Funder types: Other

Identifiers

NCT05187104

IBCE_Retinal

Details and patient eligibility

About

Treatment of age-related macular degeneration using retinal stem and progenitor cells

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Patients with age-related macular degeneration receiving standard treatment and retinal stem cells

Experimental group

Description:

Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells

Treatment:

Other: Standard treatment according to the clinical protocols

Biological: Cultured retinal stem and progenitor cells

Patients with age-related macular degeneration receiving standard treatment

Active Comparator group

Description:

Patients with age-related macular degeneration receiving standard treatment

Treatment:

Other: Standard treatment according to the clinical protocols