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

NCT02153268 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-01-12

No results posted yet for this study

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

Conditions

  • Bone Void in the Maxillofacial Area

Interventions

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.

Sponsors & Collaborators

  • BonusBio Group Ltd

    lead INDUSTRY

Principal Investigators

  • Yaniv Stolero, Dr · MY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02153268 on ClinicalTrials.gov