Clinical Trial: Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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" (Nucle

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.

Detailed Summary: 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.
Sponsor: Histograft Co., Ltd.

Current Primary Outcome: 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.



Original Primary Outcome: Quantity of newly formed bone tissue 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)
  • volume.


Current Secondary Outcome:

  • Adverse Events and Serious Adverse Events [ Time Frame: 6 months ]
    Evaluation of the Adverse Events and Serious Adverse Events frequency
  • 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


Original Secondary Outcome: Same as current

Information By: Histograft Co., Ltd.

Dates:
Date Received: March 5, 2017
Date Started: March 6, 2017
Date Completion: December 31, 2017
Last Updated: March 9, 2017
Last Verified: March 2017