Treatment of Patients With Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles

Study Overview
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Brief Summary
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Treatment of patients with segmental bone tissue defects using mesenchymal stem cells enriched by extracellular vesicles

Detailed Description
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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

Official Title
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Treatment of Patients With Segmental Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles

Conditions
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Segmental Fracture - Bone Loss

Intervention / Treatment
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* Biological: Mesenchymal stem cells enriched by extracellular vesicles
* Other: Standard treatment of bone defects


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles<br>Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles | Biological: Mesenchymal stem cells enriched by extracellular vesicles<br>* Mesenchymal stem cells enriched by extracellular vesicles<br>Other: Standard treatment of bone defects<br>* Standard surgical treatment of bone defects<br>|
| Active Comparator: Patients with bone defects receiving standard treatment<br>Patients with bone defects receiving standard surgical treatment | Other: Standard treatment of bone defects<br>* Standard surgical treatment of bone defects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 year | 
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 month | 
| Percent of completely recovered patients with segmental bone tissue defects | Percent of completely recovered patients with segmental bone tissue defects | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone defects, mesenchymal stem cells, extracellular vesicles