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

August 26, 2022 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional 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
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
Time Frame: 1 month
Determination of adverse effects associated with the therapy
1 month
Adverse effects associated with the therapy
Time Frame: 1 year
Determination of adverse effects associated with the therapy
1 year
Percent of completely recovered patients with segmental bone tissue defects
Time Frame: 1 year
Percent of completely recovered patients with segmental bone tissue defects
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Segmental Fracture - Bone Loss

Clinical Trials on Mesenchymal stem cells enriched by extracellular vesicles

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe