Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration (NCT02153268) | Clinical Trial Compass
CompletedPhase 1/2
Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration
Israel11 participantsStarted 2014-02
Plain-language 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 implantation in the following two clinical indications:
1. Bone augmentation (e.g. sinus augmentation)
2. Bone grafting after removal of cysts from jaws
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion Criteria:
* Subjects with recorded medical history diseases as: diabetes mellitus, heart diseases, renal failure, osteoporosis.
* Subject treated with systemic steroid treatment
* Subjects wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
BonoFill is safe
Timeframe: approximately 6 month follow up after implantation