Bone Void in the Maxillofacial AreaPhase 1/2NCT02153268
Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration
A Phase 1/2 study testing Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study in people with Bone Void in the Maxillofacial Area, run by BonusBio Group Ltd at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bone Void in the Maxillofacial Area
- What is being tested?
- Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Dec 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Bone augmentation (e.g. sinus augmentation)
- Bone grafting after removal of cysts from jaws
Read the detailed description
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.
- Conditions
- Bone Void in the Maxillofacial Area
- Being tested
- Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study
- Keywords
- Safety, efficacy, BonoFill, bone filler, autologous adipose tissue derived cells (HATDCs), Bone augmentation, sinus augmentation, Bone grafting after removal of cysts from jaws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on studyProcedure or surgery
Also called BonoFill is an Biological, cell therapy Product that complies with the definition of Somatic Cell Therapies, BonoFill is an autologous Human Adipose Tissue Derived Cells (HATDCs) based product, combined with OraGraft® mineral particles.
Liposuction - will be performed on Visit 2, BonoFill will be based on subject's autologous Human Adipose Tissue Derived Cells (HATDCs).
BonoFill Transplantation will be performed on Visit 6. BonoFill will be administrated to the subject in a single session at one tested cell dose.
| Study group | Role | What they receive |
|---|---|---|
| single arm, Liposuction, BonoFill Transplantation | Experimental | * Liposuction - will be performed on Visit 2 for all eligible subjects
* BonoFill Transplantation - will be performed on Visit 6 for all eligible subjects Receives: Procedure: Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study |
What is being measured
The primary outcome is the main question the study is designed to answer.
BonoFill is safe
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.
Measured: approximately 6 month follow up after implantation
Secondary outcomes (1)
BonoFill is efficient
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.
Measured: approximately 6 month follow up after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Void in the Maxillofacial AreaStudies 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- BonusBio Group Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaniv Stolero, Dr, Principal investigator, MY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153268
- Sponsor's protocol ID
- CP-BNS-02
- Status last verified
- Jan 2017
- First submitted
- 20 Apr 2014
- Last updated
- 12 Jan 2017
- 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 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02153268
- Acronym / sponsor ID
- CP-BNS-02
- Conditions
- Bone Void in the Maxillofacial Area
- Keywords
- Safety, efficacy, BonoFill, bone filler, autologous adipose tissue derived cells (HATDCs), Bone augmentation, sinus augmentation, Bone grafting after removal of cysts from jaws
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- BonusBio Group LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Jun 2014 (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.
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:
- Bone augmentation (e.g. sinus augmentation)
- Bone grafting after removal of cysts from jaws
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm, Liposuction, BonoFill Transplantation | Experimental | Procedure: Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study* Liposuction - will be performed on Visit 2 for all eligible subjects * BonoFill Transplantation - will be performed on Visit 6 for all eligible subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (15 listed)
- 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)
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 |
|---|---|---|
| Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on studyAlso: BonoFill is an Biological, cell therapy Product that complies with the definition of Somatic Cell Therapies, BonoFill is an autologous Human Adipose Tissue Derived Cells (HATDCs) based product, combined with OraGraft® mineral particles.Liposuction - will be performed on Visit 2, BonoFill will be based on subject's autologous Human Adipose Tissue Derived Cells (HATDCs). BonoFill Transplantation will be performed on Visit 6. BonoFill will be administrated to the subject in a single session at one tested cell dose. | Procedure or surgery | single arm, Liposuction, BonoFill Transplantation |
Primary outcome
BonoFill is safe
Time frame: approximately 6 month follow up after implantation
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.
1 secondary outcome
BonoFill is efficient
Time frame: approximately 6 month follow up after 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 12 Jan 2017.
- Individual participant dataSharing planned: No
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.
Yaniv Stolero, Dr principal investigator
MY
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 Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study in people with Bone Void in the Maxillofacial Area, 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 18 inclusion and 15 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 12 Jan 2017. 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?
BonoFill is safe (time frame: approximately 6 month follow up after implantation). 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 12 Jan 2017.