Bone Void in the Maxillofacial Area Clinical Trial
Official title:
Phase I/II Open Label FIH Single Center Clinical Study Aimed to Evaluate the Safety and the Efficacy of BonoFill in Reconstructing the Bone.
Phase I/II open label first in human single center clinical study, is to evaluate the safety
and the efficacy of BonoFill as bone filler containing the patient own (autologous) adipose
tissue derived cells (HATDCs) in reconstructing the Bone Void in the maxillofacial area
approximately 6 month follow up after implantation in the following two clinical
indications:
1. Bone augmentation (e.g. sinus augmentation)
2. Bone grafting after removal of cysts from jaws
Primary endpoint: The implantation of BonoFill 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 implantation of BonoFill to the maxillary or mandible void is
efficient under the following conditions: Following BonoFill 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment