CompletedPhase 1/2

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

Israel27 participantsStarted 2016-07-23

Plain-language 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

Who can participate

Age range

18 Years – 80 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

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

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

Safety of Bonofill-ll Administration

Timeframe: 6-month clinical Follow Up

Efficacy of Bonofill-ll Administration

Timeframe: 6-month clinical Follow Up

Trial details

NCT IDNCT02842619

SponsorBonusBio Group Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-02

View on ClinicalTrials.gov More Bone Augmentation trials

Plain-language summary

Who can participate

Age range

18 Years – 80 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

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria