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

NCT ID: NCT05520125

Last Updated: 2022-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Segmental Fracture - Bone Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Mesenchymal stem cells enriched by extracellular vesicles

Intervention Type BIOLOGICAL

Mesenchymal stem cells enriched by extracellular vesicles

Standard treatment of bone defects

Intervention Type OTHER

Standard surgical treatment of bone defects

Patients with bone defects receiving standard treatment

Patients with bone defects receiving standard surgical treatment

Group Type ACTIVE_COMPARATOR

Standard treatment of bone defects

Intervention Type OTHER

Standard surgical treatment of bone defects

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mesenchymal stem cells enriched by extracellular vesicles

Mesenchymal stem cells enriched by extracellular vesicles

Intervention Type BIOLOGICAL

Standard treatment of bone defects

Standard surgical treatment of bone defects

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Belarusian Medical Academy of Post-Graduate Education

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrei Hancharou, Dr

Role: STUDY_CHAIR

Institute for biophysics and cellular engineering NAS of Belarus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Minsk, , Belarus

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belarus

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anna G Poleshko, Dr

Role: CONTACT

+375295105774

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IBCE_MSCVesicles

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BM-MNCs for Lower Extremity Compartment Syndrome Injury
NCT03880656 ACTIVE_NOT_RECRUITING PHASE1