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

Phase 1

• Conditions: Segmental Fracture - Bone Loss
• Interventions: Other: Standard treatment of bone defects; Biological: Mesenchymal stem cells enriched by extracellular vesicles

• Registration Number: NCT05520125
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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 Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Last Update Submitted: 2022-08-26
• Study First Posted: 2022-08-29
• Last Update Posted: 2022-08-29
• Study Start: 2022-11-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

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

Arm && Interventions

Group	Intervention	Description
Patients with bone defects receiving standard treatment	Standard treatment of bone defects	Patients with bone defects receiving standard surgical treatment
Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles	Mesenchymal stem cells enriched by extracellular vesicles	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	Standard treatment of bone defects	Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles

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

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus