Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-02-20 @ 6:41 AM
Study NCT ID:
NCT02153268
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2014-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration
Sponsor:
BonusBio Group Ltd
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1. Bone augmentation (e.g. sinus augmentation)
2. Bone grafting after removal of cysts from jaws
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: