Treatment of Patients With Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles
NCT ID: NCT05520125
Last Updated: 2022-08-29
Study Results
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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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2022-11-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles
Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles
Mesenchymal stem cells enriched by extracellular vesicles
Mesenchymal stem cells enriched by extracellular vesicles
Standard treatment of bone defects
Standard surgical treatment of bone defects
Patients with bone defects receiving standard treatment
Patients with bone defects receiving standard surgical treatment
Standard treatment of bone defects
Standard surgical treatment of bone defects
Interventions
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Mesenchymal stem cells enriched by extracellular vesicles
Mesenchymal stem cells enriched by extracellular vesicles
Standard treatment of bone defects
Standard surgical treatment of bone defects
Eligibility Criteria
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Inclusion Criteria
* non-union fractures of the tubular bones of the upper limb;
* segmental defects of the bone tissue of the tubular bones of the upper limbs;
* absence of severe comorbidity worsening the patient's prognosis.
Exclusion Criteria
* acute inflammatory processes;
* viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections;
* autoimmune diseases;
* allergic reactions in the acute stage, established hypersensitivity to any component of the biomedical cell product;
* mental and behavioral disorders that make it impossible for patients to participate in the study, drug and/or alcohol addiction;
* patients with malignant tumors including a history.
18 Years
50 Years
ALL
No
Sponsors
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Belarusian Medical Academy of Post-Graduate Education
OTHER
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
OTHER_GOV
Responsible Party
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Principal Investigators
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Andrei Hancharou, Dr
Role: STUDY_CHAIR
Institute for biophysics and cellular engineering NAS of Belarus
Locations
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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, , Belarus
Countries
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Central Contacts
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Other Identifiers
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IBCE_MSCVesicles
Identifier Type: -
Identifier Source: org_study_id
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