Segmental Fracture - Bone Loss
Conditions
Keywords
bone defects, mesenchymal stem cells, extracellular vesicles
Brief summary
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
Interventions
BIOLOGICALMesenchymal stem cells enriched by extracellular vesicles
Mesenchymal stem cells enriched by extracellular vesicles
OTHERStandard treatment of bone defects
Standard surgical treatment of bone defects
Sponsors
Belarusian Medical Academy of Post-Graduate Education
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects associated with the therapy | 1 year | Determination of adverse effects associated with the therapy |
| Percent of completely recovered patients with segmental bone tissue defects | 1 year | Percent of completely recovered patients with segmental bone tissue defects |
Countries
Belarus
Contacts
Primary ContactAnna G Poleshko, Dr
Outcome results
None listed