Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration

NCT02153268 | Completed Phase 1

• 1 other identifier: CP-BNS-02
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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. 1.Bone augmentation (e.g. sinus augmentation)
2. 2.Bone grafting after removal of cysts from jaws

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

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 6 month follow up after implantation

Secondary Outcomes (1)

• BonoFill is efficient

  approximately 6 month follow up after implantation

Study Arms (1)

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

Procedure: Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study

Interventions

Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study PROCEDURE

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.

Also known as: 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.

single arm, Liposuction, BonoFill Transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BonusBio Group Ltd: lead

Study Sites (1)

Dr. Ephraim Zur Dental Clinic

Kfar Saba, Israel

Location

Study Officials

• Yaniv Stolero, Dr

  MY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2014
• First Posted: June 3, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)