NCT05520125

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

August 26, 2022

Last Update Submit

August 26, 2022

Conditions

Segmental Fracture - Bone Loss

Keywords

bone defects, mesenchymal stem cells, extracellular vesicles

Outcome Measures

Primary Outcomes (3)

  • Adverse effects associated with the therapy

    Determination of adverse effects associated with the therapy

    1 year

  • Adverse effects associated with the therapy

    Determination of adverse effects associated with the therapy

    1 month

  • Percent of completely recovered patients with segmental bone tissue defects

    Percent of completely recovered patients with segmental bone tissue defects

    1 year

Study Arms (2)

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

EXPERIMENTAL

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

Biological: Mesenchymal stem cells enriched by extracellular vesiclesOther: Standard treatment of bone defects

Patients with bone defects receiving standard treatment

ACTIVE COMPARATOR

Patients with bone defects receiving standard surgical treatment

Other: Standard treatment of bone defects

Interventions

Mesenchymal stem cells enriched by extracellular vesiclesBIOLOGICAL

Mesenchymal stem cells enriched by extracellular vesicles

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

Standard surgical treatment of bone defects

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

Study Officials

  • Andrei Hancharou, Dr

    Institute for biophysics and cellular engineering NAS of Belarus

    STUDY CHAIR

Central Study Contacts

Anna G Poleshko, Dr

CONTACT

+375295105774renovacio888@yandex.ru

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 29, 2022

Study Start

November 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)