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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm, Liposuction, BonoFill Transplantation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BonoFill is efficient | 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. | approximately 6 month follow up after implantation |
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Inclusion Criteria:
The inclusion criteria defining the eligible subjects are divided to two groups according clinical indications:
Sinus augmentation
Bone grafting after removal of cysts from jaws
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaniv Stolero, Dr | MY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Ephraim Zur Dental Clinic | Kfar Saba | Israel |
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