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

Phase 1

• Conditions: Bone Defects
• Interventions: Biological: 3D-Tissue Engineered Bone Equivalent

• Registration Number: NCT03103295
• Lead Sponsor: A.A. Partners, LLC

Brief Summary

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

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 Timeline

• Study Start: 2015-11-20
• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D-Tissue Engineered Bone Equivalent	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).

Primary Outcome Measures

Name	Time	Method
Radiographic and MRI assessment in progression	12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting	Radiological and MRI progression of consolidation of bone fragments

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya®); 🇺🇦 Kiev, Ukraine