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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103295
Recruitment Status : Unknown
Verified May 2017 by A.A. Partners, LLC.
Recruitment status was:  Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Bone Defects Biological: 3D-Tissue Engineered Bone Equivalent Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Traumatic Bone Defects Treatment With Use of 3D Tissue Engineered Equivalent.
Actual Study Start Date : November 20, 2015
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : December 20, 2018

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 Name: Tissue-engineered bone-like construct transplantation




Primary Outcome Measures :
  1. Radiographic and MRI assessment in progression [ Time Frame: 12 months +3 years following 3D Tissue Engineered Bone Equivalent grafting ]
    Radiological and MRI progression of consolidation of bone fragments


Secondary Outcome Measures :
  1. Reduction of pain using VAS [ Time Frame: 6 months ]
    Patients feel less pain during use of fractured limb

  2. Cost analysis based on length of hospital stay [ Time Frame: 6 months ]
    Cost benefit of 3D-TEBE transplantation by reduction of hospital admission time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103295


Locations
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Ukraine
LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya®)
Kiev, Ukraine, 03115, 9, I. Kramskogo Str.
Sponsors and Collaborators
A.A. Partners, LLC
Investigators
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Principal Investigator: Volodymyr M. Oksymets, MD,PhD,DSci LIMITED LIABILITY COMPANY "A.A. PARTNERS" (Medical company ilaya® ),
Additional Information:
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Responsible Party: A.A. Partners, LLC
ClinicalTrials.gov Identifier: NCT03103295    
Other Study ID Numbers: MSC-P2-14
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by A.A. Partners, LLC:
tissue engineering,
regeneration,
repair,
traumatic bone defects,
regenerative therapy