Segmental Fracture - Bone LossPhase 1/2NCT05520125
Treatment of Patients With Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles
A Phase 1/2 study testing Mesenchymal stem cells enriched by extracellular vesicles and Standard treatment of bone defects in people with Segmental Fracture - Bone Loss, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of patients with segmental bone tissue defects using mesenchymal stem cells enriched by extracellular vesicles Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Segmental Fracture - Bone Loss
- What is being tested?
- Mesenchymal stem cells enriched by extracellular vesicles and Standard treatment of bone defects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Nov 2022to 31 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
Official title: 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
Read the 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
- Conditions
- Segmental Fracture - Bone Loss
- Being tested
- Mesenchymal stem cells enriched by extracellular vesicles, Standard treatment of bone defects
- Keywords
- bone defects, mesenchymal stem cells, extracellular vesicles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cells enriched by extracellular vesiclesBiological
Mesenchymal stem cells enriched by extracellular vesicles
Standard treatment of bone defectsOther
Standard surgical treatment of bone defects
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Mesenchymal stem cells enriched by extracellular vesicles; Other: Standard treatment of bone defects |
| Patients with bone defects receiving standard treatment | Active comparator | Patients with bone defects receiving standard surgical treatment Receives: Other: Standard treatment of bone defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 month
Percent of completely recovered patients with segmental bone tissue defects
Percent of completely recovered patients with segmental bone tissue defects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Segmental Fracture - Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education
- Responsible party
- Sponsor
- Investigators
- Andrei Hancharou, Dr, Study chair, Institute for biophysics and cellular engineering NAS of Belarus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520125
- Sponsor's protocol ID
- IBCE_MSCVesicles
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Segmental Bone Tissue Defects Using Mesenchymal Stem Cells Enriched by Extracellular Vesicles
- ClinicalTrials.gov ID
- NCT05520125
- Acronym / sponsor ID
- IBCE_MSCVesicles
- Conditions
- Segmental Fracture - Bone Loss
- Keywords
- bone defects, mesenchymal stem cells, extracellular vesicles
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of patients with segmental bone tissue defects using mesenchymal stem cells enriched by extracellular vesicles
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles | Experimental | Biological: Mesenchymal stem cells enriched by extracellular vesicles, Other: Standard treatment of bone defectsPatients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles |
| Patients with bone defects receiving standard treatment | Active comparator | Other: Standard treatment of bone defectsPatients with bone defects receiving standard surgical treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cells enriched by extracellular vesiclesMesenchymal stem cells enriched by extracellular vesicles | Biological | Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles |
| Standard treatment of bone defectsStandard surgical treatment of bone defects | Other | Patients with bone defects receiving standard treatment, Patients with bone defects receiving standard treatment and MSC enriched with extracellular vesicles |
Primary outcome
Adverse effects associated with the therapy
Time frame: 1 year
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Time frame: 1 month
Determination of adverse effects associated with the therapy
Percent of completely recovered patients with segmental bone tissue defects
Time frame: 1 year
Percent of completely recovered patients with segmental bone tissue defects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Hancharou, Dr study chair
Institute for biophysics and cellular engineering NAS of Belarus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal stem cells enriched by extracellular vesicles and Standard treatment of bone defects in people with Segmental Fracture - Bone Loss, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna G Poleshko, Dr (+375295105774, renovacio888@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effects associated with the therapy (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.