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Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration

Sponsored by BonusBio Group Ltd

About this trial

Last updated 8 years ago

Study ID

CP-BNS-02

Status

Completed

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 9 years ago

What is this trial about?

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

What are the participation requirements?

Yes

Inclusion Criteria

The inclusion criteria defining the eligible subjects are divided to two groups according clinical indications: Sinus augmentation - Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests - Subjects that have a rehabilitation dentist and rehabilitation program - Up to dated panoramic X-Ray. - Subjects who provided written informed consent to participate in the study, able to understand study procedure and agree for follow up procedures - Healthy conditions of Maxillary Sinuses and Oral Mucosa. - Sub-antral bone at least 4 mm as measured on CBCT/CT. - Have a good oral hygiene condition as per investigator discretion. Bone grafting after removal of cysts from jaws - Healthy subject. - Subjects that have a rehabilitation dental treatment. - Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts. - Subjects referred to oral & maxillofacial Dpt for removal of cysts after diagnosis of the cyst type. - Healthy bone determined by X-ray. - Have a good oral hygiene condition. - Subject that does not participate in other clinical study. - Subject able to read and understand and sign the informed consent

No

Exclusion Criteria

- Subjects with recorded medical history diseases as: diabetes mellitus, heart diseases, renal failure, osteoporosis. - Subject treated with systemic steroid treatment - Subjects with known autoimmune diseases, such as: Addison's disease Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome Systemic lupus erythematosus, Type I diabetes. - Subjects that have Vitiligo and/or known scar healing problems (keloid formation). - Subjects treated with anticoagulation medication (such as Coumadin, Plavix and other similar medications) - Subjects treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications) - Subjects with a history of Chemotherapy or Radiotherapy treatment - In case of sinus augmentation - Unhealthy conditions of Maxillary Sinuses. - Subjects with current active infection or illness - Subjects participating in another clinical trial 30 days prior to and during the study period - Pregnant or lactating woman. Pregnancy will be verified by urine test during screening - Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation - Subjects with any known allergy for anesthesia - Positive serology for either HIV, hepatitis B or hepatitis C - Abnormal clinically significant as per investigator's judgment laboratory test and exams findings

Locations

Location

Status