Treatment of Patients With Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles
Phase 1
- Conditions
- Segmental Fracture - Bone Loss
- Registration Number
- NCT05520125
- Brief Summary
Treatment of patients with segmental bone tissue defects using mesenchymal stem cells enriched by extracellular vesicles
- Detailed Description
The aims of the project are to develop a technology for obtaining mesenchymal stem cells extracellular vesicles; to develop biomedical cell product based on mesenchymal stem cells enriched with own extracellular vesicles; to conduct the clinical trials of the biomedical cell product in the treatment of patients with segmental bone tissue defects
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- age 18-50 years;
- 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
- pregnancy;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent of completely recovered patients with segmental bone tissue defects 1 year Percent of completely recovered patients with segmental bone tissue defects
Adverse effects associated with the therapy 1 month Determination of adverse effects associated with the therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
🇧🇾Minsk, Belarus
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus🇧🇾Minsk, Belarus