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Filling Bone Defects/Voids With Autologous BonoFill 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153268
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
BonusBio Group Ltd

Brief 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

Condition or disease Intervention/treatment Phase
Bone Void in the Maxillofacial Area Procedure: Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : February 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single arm, Liposuction, BonoFill Transplantation
  • Liposuction - will be performed on Visit 2 for all eligible subjects
  • BonoFill Transplantation - will be performed on Visit 6 for all eligible subjects
Procedure: Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study

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.

Other Names:
  • 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. BonoFill is efficient [ Time Frame: approximately 6 month follow up after implantation ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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)
  • 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

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): NCT02153268


Locations
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Israel
Dr. Ephraim Zur Dental Clinic
Kfar Saba, Israel
Sponsors and Collaborators
BonusBio Group Ltd
Investigators
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Principal Investigator: Yaniv Stolero, Dr MY

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Responsible Party: BonusBio Group Ltd
ClinicalTrials.gov Identifier: NCT02153268    
Other Study ID Numbers: CP-BNS-02
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by BonusBio Group Ltd:
Safety
efficacy
BonoFill
bone filler
autologous adipose tissue derived cells (HATDCs)
Bone augmentation
sinus augmentation
Bone grafting after removal of cysts from jaws