Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842619
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
BonusBio Group Ltd

Brief 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

Condition or disease Intervention/treatment Phase
Bone Augmentation Bone Grafts Biological: BonoFill-II Phase 1 Phase 2

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Open Label First in Human Single Center Clinical Study Aimed to Evaluate the Safety and Efficacy of BonoFill-II in Reconstructing Maxillofacial Bone
Actual Study Start Date : July 23, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Intervention Arm
1 Arm - IMP treatment arm
Biological: BonoFill-II

Sinus augmentation - Surgery will be performed by either open or close sinus augmentation as per investigator discretion and as per common medical practice. After the elevation, BonoFill-II will be transplanted on the residual sub-antral bone.

Bone grafting after removal of cysts from jaws - Treatment will be performed according to the size of the cyst: in relatively small cyst total enucleation will be performed. In large cysts, a process of marsupialization will be performed. The entire cyst will be removed, including the epithelium layer, and the BonoFill-II product will be used for filling.





Primary Outcome Measures :
  1. Safety of Bonofill-ll Administration [ Time Frame: 6-month clinical Follow Up ]
    The study will assess the safety of the BonoFill-II drug product post transplantation by demonstrating no treatment-related adverse events such as chronic bone infection (Osteomyelitis) or significant changes in complete blood counts. adverse events will be assessed by type, severity, seriousness, relatedness, incidence, and duration.

  2. Efficacy of Bonofill-ll Administration [ Time Frame: 6-month clinical Follow Up ]
    Following BonoFill-II transplantation, the bone regeneration in the operated site will be evaluated using CT or panoramic X Ray. Bone formation at the implantation site inside the maxillary sinus will be evaluated by measuring the bone height (mm) at the end of the study (residual + Augmented bone at 3 evenly-spaced locations) and comparing to measurements of bone height of the residual bone only prior to Bonofill-ll administration. Efficacy will be evaluated also by having a stable dental implants at the uncovering procedure by the end of the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

GENERAL

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

SINUS AUGMENTATION

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

BONE GRAFTING AFTER REMOVAL OF CYSTS FROM JAWS

  1. 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.
  2. Subject's cyst was removed after diagnosis of the cyst type

Exclusion Criteria:

  1. Subject with a recorded medical history of diseases such as diabetes mellitus, heart diseases, renal failure, osteoporosis, Multiple sclerosis,
  2. Subject treated with systemic steroids
  3. 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.
  4. Subject has vitiligo or a known scar healing problems (keloid formation)
  5. Subject treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
  6. Subjects underwent one of the following treatments up to 12 months prior to Visit 1: Chemotherapy, Radiotherqapy
  7. In case of sinus augmentation - unhealthy conditions of Maxillary Sinuses.
  8. Subject with current active infection or illness.
  9. Subject participating in another clinical trial 30 days prior to and during the study period.
  10. Subject is a pregnant or lactating woman. Pregnancy will be verified by urine test during screening.
  11. Subject has a known history of any significant medical disorder, which in the investigator's discretion contraindicates the subject's participation.
  12. Subject has a known allergy for anesthesia.
  13. Subjects with known allergy to hyaluronic acid.
  14. Subjects with known allergy to HypoThermosol® or Dextran-40.
  15. Subjects with known allergy to any of the antibiotics: Bacitracin, Gentamicin and/or Polymyxin B Sulfate.
  16. Positive serology for either HIV, hepatitis B or hepatitis C.
  17. Abnormal clinically significant laboratory test and exams findings as per investigator's discretion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842619


Contacts
Layout table for location contacts
Contact: Ephraim Tzur, DMD 972-53-734-5356 drefitzur@gmail.com

Locations
Layout table for location information
Israel
Oral and Maxillofacial Surgery Clinic - Beit Merik Recruiting
Kfar Saba, Israel
Contact: Sahar Tzur    972-50-7891113    moonstruck6@gmail.com   
Sub-Investigator: Alex Levenberg, MD         
Sub-Investigator: Shlomo Bulvik, MD         
Sponsors and Collaborators
BonusBio Group Ltd
Investigators
Layout table for investigator information
Study Director: Nir Shtayer, DVM Bonus BioGroup
Layout table for additonal information
Responsible Party: BonusBio Group Ltd
ClinicalTrials.gov Identifier: NCT02842619    
Other Study ID Numbers: CP-BNS03
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No