3D Tissue Engineered Bone Equivalent for Treatment of Traumatic Bone Defects

Study Overview
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Brief Summary
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This study investigates safety and efficacy of traumatic bone defects treatment with use of 3D tissue engineered bone equivalent (3D-TEBE). The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient treatment for patients with traumatic long bone defects of critical size.

Detailed Description
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This new method of critical sized long bone defects treatment is under clinical development. Treatment of critical sized bone defects is an actual clinical challenge. The gold standard in this case is autologous bone grafting. The method disadvantage is associated with limited donor bone resources. Based on our preliminary clinical trial positive results on use of autologous cultured bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs) in traumatology, our aim was to develop 3D tissue-engineered bone equivalent transplantation technology for restoration of critical sized bone defects. The proposed 3D-TEBE transplantation for bone defects of critical size treatment expecting to restore the bone integrity, form new bone tissue in a site of bone defect, and reduce the rehabilitation period of a patient. The data obtained from this study will have practical implications for the treatment of reparative osteogenesis alterations and will be based on the principles of evidence-based medicine

Official Title
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Safety and Efficacy Study of Traumatic Bone Defects Treatment With Use of 3D Tissue Engineered Equivalent.

Conditions
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Bone Defects

Intervention / Treatment
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* Biological: 3D-Tissue Engineered Bone Equivalent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 60 years Patients with long bone defects of critical size of the traumatic genesis; Lack of consolidation of bone fragments for at least 9 months; At least two attempts to achieve bone consolidation using traditional methods of treatment; A negative pregnancy test at women of childbearing age; Confirmation of participation in the study by signing The Written Informed Consent, personally or through a responsible caretaker; Exclusion Criteria: The infection in the area of bone defect; History of prior cancer; Diabetes; Severe chronic liver diseases or kidneys disease in history Pregnancy; The presence of vascular, endocrine and somatic pathology which has a direct impact on the osteoreparation; Any other physical diseases in decompensation or subcompensation, or those that are rated as severe or moderate; Therapeutic issues or psychiatric disorders of a patient which would make the subject unsuitable to participate in this study or to complete it; Participation in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-Tissue Engineered Bone Equivalent<br>Patients with bone defects of critical size of long bones 3D Tissue Engineered Bone Equivalent: allogeneic or xenogeneic partially demineralized bone matrix (DBM) and plasma-derived fibrin gel seeded with autologous cultured bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs), periosteal progenitor cells (PPCs), peripheral blood-derived endothelial progenitor cells (PB-EPCs). | Biological: 3D-Tissue Engineered Bone Equivalent<br>* Administrated for operative delivery of 3D-Tissue Engineered Bone Equivalent<br>* Other names: Tissue-engineered bone-like construct transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic and MRI assessment in progression | Radiological and MRI progression of consolidation of bone fragments | 12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pain using VAS | Patients feel less pain during use of fractured limb | 6 months | 
| Cost analysis based on length of hospital stay | Cost benefit of 3D-TEBE transplantation by reduction of hospital admission time | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tissue engineering,, regeneration,, repair,, traumatic bone defects,, regenerative therapy