Treatment of Patients With Segmental Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Percent of completely recovered patients with segmental bone tissue defects
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Standard treatment of bone defects (Other)
Patients with bone defects receiving standard treatment
Patients with bone defects receiving standard surgical treatment
Intervention: Standard treatment of bone defects (Other)
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
Intervention: Mesenchymal stem cells enriched by extracellular vesicles (Biological)
Outcomes
Primary Outcomes
Percent of completely recovered patients with segmental bone tissue defects
Time Frame: 1 year
Percent of completely recovered patients with segmental bone tissue defects
Adverse effects associated with the therapy
Time Frame: 1 month
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Time Frame: 1 year
Determination of adverse effects associated with the therapy
Secondary Outcomes
No secondary outcomes reported