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Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

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ClinicalTrials.gov Identifier: NCT03076138
Recruitment Status : Unknown
Verified March 2017 by Histograft Co., Ltd..
Recruitment status was:  Enrolling by invitation
First Posted : March 10, 2017
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Moscow State University of Medicine and Dentistry
Information provided by (Responsible Party):
Histograft Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.

Condition or disease Intervention/treatment Phase
Bone Cysts Bone Atrophy Bone Deformity Bone Fracture Bone Loss Tooth Loss Device: Gene-activated matrix (OCP + plasmid DNA with VEGF gene) Not Applicable

Detailed Description:
All participants of the study will receive standard treatment according to the medical care standards for diseases and pathological conditions characterized by maxillofacial bone defects and/or alveolar ridge atrophy. Bone grafting procedures as part of the surgical treatment will be performed with the use of investigated medical device. The safety and efficacy of the implanted gene-activated bone substitute will be evaluated by clinical examination, comprehensive laboratory tests, and computer tomography within 6 months after surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Trial of the Safety and Efficacy of the Medical Device "Bone Substitute Based on Octacalcium Phosphate and Biologically Active Nucleic Acids for Bone Tissue Regeneration" (Nucleostim-VEGF)
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : November 6, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test group
Bone grafting with gene-activated matrix (OCP + plasmid DNA with VEGF gene)
Device: Gene-activated matrix (OCP + plasmid DNA with VEGF gene)
Bone grafting procedure with investigated medical device




Primary Outcome Measures :
  1. Bone tissue formation in the field of gene-activated bone substitute implantation [ Time Frame: 6 months ]

    To determine the quantity of newly formed bone tissue the following morphometric parameters will be measured on CT scan using special tools ("ROI", region of interest, etc.):

    • average density (in HU);
    • size (length, width, height) and volume.

    All together both measurements allow to determine "bone tissue formation" as a value derived from the presence of newly formed bone tissue and its volume correspondence with the quantity of the material implanted.



Secondary Outcome Measures :
  1. Adverse Events and Serious Adverse Events [ Time Frame: 6 months ]
    Evaluation of the Adverse Events and Serious Adverse Events frequency

  2. Surgical failure rate [ Time Frame: 6 months ]
    Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute



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:

  • obtained voluntary informed consent for participation in the clinical study;
  • congenital and acquired maxillofacial bone defects (sockets of extracted teeth, bone defects after injuries, surgeries, removal of benign neoplasms and pseudotumors, etc.) or alveolar ridge atrophy.

Exclusion Criteria:

  • not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study;
  • decompensated chronic visceral diseases;
  • clinically significant laboratory abnormalities;
  • HIV, HBV and HCV antibodies in serum;
  • alcohol consumption within 4 days prior the study;
  • history of drug addiction;
  • participation in other clinical trials (or administration of study products) within 3 months prior the study;
  • conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
  • pregnancy or lactation;
  • malignancies including post-treatment period (surgical, chemotherapy, radiation therapy both alone and in different combinations) less than 5 years prior the study.

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): NCT03076138


Locations
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Russian Federation
A.I. Moscow State University of Medicine and Dentistry
Moscow, Russian Federation, 127473
Sponsors and Collaborators
Histograft Co., Ltd.
Moscow State University of Medicine and Dentistry
Investigators
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Principal Investigator: Alexey Y. Drobyshev, MD,PhD,Prof. A.I. Evdokimov Moscow State University of Medicine and Dentistry

Publications:
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Responsible Party: Histograft Co., Ltd.
ClinicalTrials.gov Identifier: NCT03076138     History of Changes
Other Study ID Numbers: RU-Histograft-20-08-2016
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Detailed results of the study will be published in a specialized peer-reviewed scientific journal with an open access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Histograft Co., Ltd.:
Gene-activated matrix
Bone substitute
Bone grafting
Dental implantation
gene therapy
plasmid DNA
VEGF gene
octacalcium phosphate

Additional relevant MeSH terms:
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Tooth Loss
Atrophy
Fractures, Bone
Bone Cysts
Pathological Conditions, Anatomical
Wounds and Injuries
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Cysts
Neoplasms
Bone Diseases
Musculoskeletal Diseases