Filling Bone Defects/Voids With Autologous BonoFill-II for Maxillofacial Bone Regeneration

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    BonusBio Group Ltd
Updated on 7 February 2023

Summary

The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as a bone filler containing the patient's own (autologous) adipose (fat) tissue-derived cells in reconstructing bone in two clinical indications:

  1. Bone augmentation (e.g. sinus augmentation)
  2. Bone grafting after removal of cysts from jaws

Description

Primary endpoint:

The transplantation of BonoFill-II to the maxillary or mandible defect/void is safe under the following conditions: No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health.

Secondary endpoint:

The transplantation of BonoFill-II to the maxillary or mandible void is efficient under the following conditions: Following BonoFill-II implantation, the bone regeneration in the operated site was significantly accelerated. Also, the bone defects/voids were filled with a significant amount of bone tissue.

Details
Condition Bone Augmentation, Bone Grafts
Treatment BonoFill-II
Clinical Study IdentifierNCT02842619
SponsorBonusBio Group Ltd
Last Modified on7 February 2023

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