3D Tissue Engineered Bone Equivalent for Treatment of Traumatic Bone Defects (3-D-TEBE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Bone Defects
• Intervention / Treatment: Biological: 3D-Tissue Engineered Bone Equivalent

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Ukraine
  • Kiev, Ukraine, 03115, 9, I. Kramskogo Str.
    • LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya®)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: Tissue-engineered bone-like construct transplantation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: A.A. Partners, LLC
• Investigators: Principal Investigator: Volodymyr M. Oksymets, MD,PhD,DSci, LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya® ),

Publications and helpful links

Helpful Links

• RG Vasyliev, DO Zubov, AE Rodnichenko, OS Gubar, AV Zlatska, VM Oksymets. Bone tissue engineering for critical sized bone defects// European Cells and Materials Vol. 31. Suppl. 1, 2016. - Page P410
• Volodymyr Oksymets, Dmytro Zubov, Roman Vasyliev, Anzhela Rodnichenko, Olga Gubar, Alena Zlatska, Vitaliy Oksymets. Tissue-engineered bone for traumatology and orthopedics: biotechnology aspects and clinical outcomes.//Absract book. Posters. 37th SICOT

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2015
• Primary Completion (ANTICIPATED): December 20, 2018
• Study Completion (ANTICIPATED): December 20, 2018

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (ACTUAL): April 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: regenerative therapy; tissue engineering,; regeneration,; repair,; traumatic bone defects,
• Other Study ID Numbers: MSC-P2-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No