Back to resultsTreatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
Primary Purpose
Age-Related Macular Degeneration
Status
Enrolling by invitation
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Cultured retinal stem and progenitor cells
Standard treatment according to the clinical protocols
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
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
Sites / Locations
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with age-related macular degeneration receiving standard treatment and retinal stem cells
Patients with age-related macular degeneration receiving standard treatment
Arm Description
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
Outcomes
Primary Outcome Measures
Visual acuity
Determination of visual acuity after the therapy
Visual acuity
Determination of visual acuity after the therapy
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT05187104
First Posted
December 24, 2021
Last Updated
September 9, 2022
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05187104
Brief Title
Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
Official Title
Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with age-related macular degeneration receiving standard treatment and retinal stem cells
Arm Type
Experimental
Arm Description
Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells
Arm Title
Patients with age-related macular degeneration receiving standard treatment
Arm Type
Active Comparator
Arm Description
Patients with age-related macular degeneration receiving standard treatment
Intervention Type
Biological
Intervention Name(s)
Cultured retinal stem and progenitor cells
Intervention Description
Cultured retinal stem and progenitor cells injected subretinally
Intervention Type
Other
Intervention Name(s)
Standard treatment according to the clinical protocols
Intervention Description
Standard treatment of age-related macular degeneration according to the clinical protocols
Primary Outcome Measure Information:
Title
Visual acuity
Description
Determination of visual acuity after the therapy
Time Frame
1 month
Title
Visual acuity
Description
Determination of visual acuity after the therapy
Time Frame
1 year
Title
Adverse effects associated with the therapy
Description
Determination of adverse effects associated with the therapy
Time Frame
1 month
Title
Adverse effects associated with the therapy
Description
Determination of adverse effects associated with the therapy
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludmila Marchenko, Prof
Organizational Affiliation
Belarusian State Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zinaida Kvacheva, Dr
Organizational Affiliation
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
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