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

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05187104
• Other study ID #: IBCE_Retinal
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Belarus	Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Determination of visual acuity after the therapy	1 month
Primary	Visual acuity	Determination of visual acuity after the therapy	1 year
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 month
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 year