Bone AugmentationPhase 1/2NCT02842619
Filling Bone Defects/Voids With Autologous BonoFill-II for Maxillofacial Bone Regeneration
A Phase 1/2 study testing BonoFill-II in people with Bone Augmentation and Bone Grafts, run by BonusBio Group Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Augmentation, Bone Grafts
- What is being tested?
- BonoFill-II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jul 2016to 30 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the detailed description
Safety 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.
Efficacy endpoint:
The transplantation of BonoFill-II to the maxillary or mandible void is efficient: the bone defects/voids are filled with at least 8mm of total bone height at the transplanted area.
- Conditions
- Bone Augmentation, Bone Grafts
- Being tested
- BonoFill-II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BonoFill-IIBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 1 Arm - IMP treatment arm Receives: Biological: BonoFill-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Bonofill-ll Administration
The study will assess the safety of the BonoFill-II drug product post transplantation by demonstrating No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health.
Measured: 6-month clinical Follow Up
Efficacy of Bonofill-ll Administration
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 at the end of the study (residual + Augmented bone at 3 evenly-spaced locations). Successful bone regeneration is achieved if:
- Bone formation inside the maxillary sinus or bone void, in the area of dental implantation defined at Visit 1 (prior to BonoFill-ll transplantation), with average height (residual + augmented bone) of at least 8mm, OR
- Bone formation inside the maxillary sinus in the area of dental implantation defined at Visit 1 (prior to BonoFill-II transplantation), allowing successful dental implantation.
Measured: 6-month clinical Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start23 Jul 2016
- Primary completion2 Jun 2024
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- BonusBio Group Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vered Kivity, PhD, MBA, Study director, Bonus BioGroup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842619
- Sponsor's protocol ID
- CP-BNS03
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2015
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02842619
- Acronym / sponsor ID
- CP-BNS03
- Conditions
- Bone Augmentation, Bone Grafts
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- BonusBio Group LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2016 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Safety 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.
Efficacy endpoint:
The transplantation of BonoFill-II to the maxillary or mandible void is efficient: the bone defects/voids are filled with at least 8mm of total bone height at the transplanted area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Biological: BonoFill-II1 Arm - IMP treatment arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BonoFill-IISinus 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. | Biological | Intervention Arm |
Primary outcome
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 chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health.
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 at the end of the study (residual + Augmented bone at 3 evenly-spaced locations). Successful bone regeneration is achieved if: * Bone formation inside the maxillary sinus or bone void, in the area of dental implantation defined at Visit 1 (prior to BonoFill-ll transplantation), with average height (residual + augmented bone) of at least 8mm, OR * Bone formation inside the maxillary sinus in the area of dental implantation defined at Visit 1 (prior to BonoFill-II transplantation), allowing successful dental implantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vered Kivity, PhD, MBA study director
Bonus BioGroup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BonoFill-II in people with Bone Augmentation and Bone Grafts, run by BonusBio Group Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Bonofill-ll Administration (time frame: 6-month clinical Follow Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.