3D Tissue Engineered Bone Equivalent for Treatment of Traumatic Bone Defects (3-D-TEBE)
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|ClinicalTrials.gov Identifier: NCT03103295|
Recruitment Status : Unknown
Verified May 2017 by A.A. Partners, LLC.
Recruitment status was: Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : May 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Bone Defects||Biological: 3D-Tissue Engineered Bone Equivalent||Phase 1 Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Study of Traumatic Bone Defects Treatment With Use of 3D Tissue Engineered Equivalent.|
|Actual Study Start Date :||November 20, 2015|
|Estimated Primary Completion Date :||December 20, 2018|
|Estimated Study Completion Date :||December 20, 2018|
Experimental: 3D-Tissue Engineered Bone Equivalent
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
Administrated for operative delivery of 3D-Tissue Engineered Bone Equivalent
Other Name: Tissue-engineered bone-like construct transplantation
- Radiographic and MRI assessment in progression [ Time Frame: 12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting ]Radiological and MRI progression of consolidation of bone fragments
- Reduction of pain using VAS [ Time Frame: 6 months ]Patients feel less pain during use of fractured limb
- Cost analysis based on length of hospital stay [ Time Frame: 6 months ]Cost benefit of 3D-TEBE transplantation by reduction of hospital admission time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103295
|LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya®)|
|Kiev, Ukraine, 03115, 9, I. Kramskogo Str.|
|Principal Investigator:||Volodymyr M. Oksymets, MD,PhD,DSci||LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya® ),|