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

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ClinicalTrials.gov Identifier: NCT05187104
Recruitment Status : Not yet recruiting
First Posted : January 11, 2022
Last Update Posted : January 11, 2022
Sponsor:
Collaborator:
Belarusian State Medical University
Information provided by (Responsible Party):
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Study Description
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Brief Summary:
Treatment of age-related macular degeneration using retinal stem and progenitor cells

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Biological: Cultured retinal stem and progenitor cells Other: Standard treatment according to the clinical protocols Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 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
Active Comparator: Patients with age-related macular degeneration receiving standard treatment
Patients with age-related macular degeneration receiving standard treatment
 Other: Standard treatment according to the clinical protocols
Standard treatment of age-related macular degeneration according to the clinical protocols


Outcome Measures
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Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 1 month ]
    Determination of visual acuity after the therapy

  2. Visual acuity [ Time Frame: 1 year ]
    Determination of visual acuity after the therapy

  3. Adverse effects associated with the therapy [ Time Frame: 1 month ]
    Determination of adverse effects associated with the therapy

  4. Adverse effects associated with the therapy [ Time Frame: 1 year ]
    Determination of adverse effects associated with the therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05187104


Contacts
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Contact: Zinaida Kvacheva, Dr +375173332223 kvachzb@tut.by
Contact: Hanna Paleshka, Dr +375173332223 renovacio888@yandex.ru

Sponsors and Collaborators
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Belarusian State Medical University
Investigators
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Study Director: Ludmila Marchenko, Prof Belarusian State Medical University
Study Director: Zinaida Kvacheva, Dr the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
More Information
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Responsible Party: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
ClinicalTrials.gov Identifier: NCT05187104    
Other Study ID Numbers: IBCE_Retinal
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases