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

NCT ID: NCT05187104

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Cultured retinal stem and progenitor cells

Intervention Type BIOLOGICAL

Cultured retinal stem and progenitor cells injected subretinally

Standard treatment according to the clinical protocols

Intervention Type OTHER

Standard treatment of age-related macular degeneration according to the clinical protocols

Patients with age-related macular degeneration receiving standard treatment

Patients with age-related macular degeneration receiving standard treatment

Group Type ACTIVE_COMPARATOR

Standard treatment according to the clinical protocols

Intervention Type OTHER

Standard treatment of age-related macular degeneration according to the clinical protocols

Interventions

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Cultured retinal stem and progenitor cells

Cultured retinal stem and progenitor cells injected subretinally

Intervention Type BIOLOGICAL

Standard treatment according to the clinical protocols

Standard treatment of age-related macular degeneration according to the clinical protocols

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ludmila Marchenko, Prof

Role: STUDY_DIRECTOR

Belarusian State Medical University

Zinaida Kvacheva, Dr

Role: STUDY_DIRECTOR

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

Locations

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

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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IBCE_Retinal

Identifier Type: -

Identifier Source: org_study_id

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