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

NCT03103295 | Unknown Phase 1 DMC

• 1 other identifier: MSC-P2-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Defects

Keywords

tissue engineering,; regeneration,; repair,; traumatic bone defects,; regenerative therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reduction of pain using VAS

  6 months

• Cost analysis based on length of hospital stay

  6 months

Study Arms (1)

3D-Tissue Engineered Bone Equivalent

EXPERIMENTAL

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

Interventions

3D-Tissue Engineered Bone Equivalent BIOLOGICAL

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

Also known as: Tissue-engineered bone-like construct transplantation

3D-Tissue Engineered Bone Equivalent

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• A.A. Partners, LLC: lead

Study Sites (1)

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

Kiev, 03115, 9, I. Kramskogo Str., Ukraine

Location

Related Links

• 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 Officials

• Volodymyr M. Oksymets, MD,PhD,DSci

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 6, 2017
• Study Start: November 20, 2015
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

UA (1)