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Clinical Trials/NCT05187104
NCT05187104
Enrolling By Invitation
Phase 1

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

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Age-Related Macular Degeneration
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Enrollment
20
Locations
1
Primary Endpoint
Visual acuity
Status
Enrolling By Invitation
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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
  • 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

Outcomes

Primary Outcomes

Visual acuity

Time Frame: 1 year

Determination of visual acuity after the therapy

Adverse effects associated with the therapy

Time Frame: 1 year

Determination of adverse effects associated with the therapy

Study Sites (1)

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