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

Phase 1

• Conditions: Age-Related Macular Degeneration
• Interventions: Biological: Cultured retinal stem and progenitor cells; Other: Standard treatment according to the clinical protocols

• Registration Number: NCT05187104
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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.

Study Timeline

• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2021-12-24
• Study First Posted: 2022-01-11
• Study Start: 2022-03-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with age-related macular degeneration receiving standard treatment and retinal stem cells	Standard treatment according to the clinical protocols	Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells
Patients with age-related macular degeneration receiving standard treatment and retinal stem cells	Cultured retinal stem and progenitor cells	Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells
Patients with age-related macular degeneration receiving standard treatment	Standard treatment according to the clinical protocols	Patients with age-related macular degeneration receiving standard treatment

Primary Outcome Measures

Name	Time	Method
Visual acuity	1 year	Determination of visual acuity after the therapy
Adverse effects associated with the therapy	1 year	Determination of adverse effects associated with the therapy

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus