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

Bonus BioGroup

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Bone Grafts

Bone Augmentation

Treatments

Biological: BonoFill-II

Study type

Interventional

Funder types

Industry

Identifiers

NCT02842619

CP-BNS03

Details and patient eligibility

About

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:

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

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

GENERAL

Subject in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
Subject has a rehabilitation dentist and rehabilitation program
Up to date panoramic X-Ray/CT
Subject has provided written informed consent to participate in the study, understands all study procedures and agrees to follow up procedures
Subject is in good oral hygiene condition as per investigator's discretion

SINUS AUGMENTATION

The subjects requires sinus augmentation as per investigator's discretion
Healthy condition of Maxillary Sinuses and Oral Mucosa determined by X-ray

BONE GRAFTING AFTER REMOVAL OF CYSTS FROM JAWS

Subject who according to investigator diagnosis required removal of cysts from jaws. Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts.
Subject's cyst was removed after diagnosis of the cyst type

Exclusion criteria

Subject with a recorded medical history of diseases such as diabetes mellitus, heart diseases, renal failure, osteoporosis, Multiple sclerosis,
Subject treated with systemic steroids
Subject with a known autoimmune disease, such as Addison's disease, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus, Type I diabetes.
Subject has vitiligo or a known scar healing problems (keloid formation)
Subject treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
Subjects underwent one of the following treatments up to 12 months prior to Visit 1: Chemotherapy, Radiotherqapy
In case of sinus augmentation - unhealthy conditions of Maxillary Sinuses.
Subject with current active infection or illness.
Subject participating in another clinical trial 30 days prior to and during the study period.
Subject is a pregnant or lactating woman. Pregnancy will be verified by urine test during screening.
Subject has a known history of any significant medical disorder, which in the investigator's discretion contraindicates the subject's participation.
Subject has a known allergy for anesthesia.
Subjects with known allergy to hyaluronic acid.
Subjects with known allergy to HypoThermosol® or Dextran-40.
Subjects with known allergy to any of the antibiotics: Bacitracin, Gentamicin and/or Polymyxin B Sulfate.
Positive serology for either HIV, hepatitis B or hepatitis C.
Abnormal clinically significant laboratory test and exams findings as per investigator's discretion.