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

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Segmental Fracture - Bone Loss

Treatments: Biological: Mesenchymal stem cells enriched by extracellular vesicles; Other: Standard treatment of bone defects

Study type: Interventional

Funder types: Other

Identifiers

NCT05520125

IBCE_MSCVesicles

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles

Experimental group

Description:

Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles

Treatment:

Biological: Mesenchymal stem cells enriched by extracellular vesicles

Other: Standard treatment of bone defects

Patients with bone defects receiving standard treatment

Active Comparator group

Description:

Patients with bone defects receiving standard surgical treatment

Treatment:

Other: Standard treatment of bone defects