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

A.A. Partners, LLC20 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bone Defects

Interventions

3D-Tissue Engineered Bone EquivalentBIOLOGICAL

Administrated for operative delivery of 3D-Tissue Engineered Bone Equivalent

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya®)

Kiev, Ukraine

Outcomes

Primary Outcomes

Radiographic and MRI assessment in progression

Radiological and MRI progression of consolidation of bone fragments

Time frame: 12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting

Secondary Outcomes

Reduction of pain using VAS

Patients feel less pain during use of fractured limb

Time frame: 6 months

Cost analysis based on length of hospital stay

Cost benefit of 3D-TEBE transplantation by reduction of hospital admission time

Time frame: 6 months

Data from ClinicalTrials.gov

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