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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Segmental Fracture - Bone Loss
• Intervention / Treatment: Biological: Mesenchymal stem cells enriched by extracellular vesicles; Other: Standard treatment of bone defects

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Anna G Poleshko, Dr; Phone Number: +375295105774; Email: renovacio888@yandex.ru

Study Locations

• Belarus
  • Minsk, Belarus, 220072
    • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Collaborators: Belarusian Medical Academy of Post-Graduate Education
• Investigators: Study Chair: Andrei Hancharou, Dr, Institute for biophysics and cellular engineering NAS of Belarus

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: bone defects, mesenchymal stem cells, extracellular vesicles
• Other Study ID Numbers: IBCE_MSCVesicles

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No