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

Bone Defects Clinical Trial

— 3-D-TEBE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03103295
• Other study ID #: MSC-P2-14
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: March 31, 2017
• Last updated: May 10, 2017
• Start date: November 20, 2015
• Est. completion date: December 20, 2018

Study information

• Verified date: May 2017
• Source: A.A. Partners, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Defects

Intervention

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

Locations

Country	Name	City	State
Ukraine	LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya®)	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
A.A. Partners, LLC

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction of pain using VAS	Patients feel less pain during use of fractured limb	6 months
Secondary	Cost analysis based on length of hospital stay	Cost benefit of 3D-TEBE transplantation by reduction of hospital admission time	6 months

External 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