Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670965
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-18
First Post:
2020-12-10
Brief Title:
Release Kinetics of RhBMP-2 Using E-PRF As an Autologous Carrier an in Vitro Analysis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Release Kinetics of RhBMP-2 Using E-PRF As an Autologous Carrier an in Vitro Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This study is seeking to evaluate the binding of a commercially-available recombinant human osteoinductive growth factor rhBMP-2 to a human blood derived product scaffold enhanced Platelet-rich fibrin E-PRF and the release of such a growth factor over time in an in vitro laboratory environment The investigators will compare these release kinetics to those of the FDA approved carrier for rhBMP-2 an absorbable collagen sponge ACS a combination of E-PRF and ACS and E-PRF alone
Detailed Description:
Innovations in biomedicine and recombinant protein technology show promising advances for the regeneration of advanced alveolar defects Recombinant growth factors and biologics encourage minimally invasive procedures with improved clinical outcomeshealing times in complex oral surgery procedures Recombinant human bone morphogenic protein-2 rhBMP-2 is a morphogen that is a well-known regulator of bone formation1 and has been widely studied for bone reconstructive treatments2-6 RhBMP-2 is currently commercially available and loaded on an absorbable collagen sponge ACS This recombinant growth factor has been approved by the US Food and Drug Administration as an alternative to autogenous bone grafting in sinus augmentation and localized alveolar ridge augmentation for defects associated with extraction sockets It is also used off-label for vertical bone augmentation However there are limitations of the ACS as a carrier because it is compressible and does not ideally support soft tissues to maintain space for osteogenesis to occur Furthermore the release kinetics of rhBMP-2 in a standardized in vitro environment from its ACS carrier are unknown and it is further unknown how such release would compare to the use of other carriers Subcutaneous implantation in rats and implantation at orthotropic sites in rats and rabbits has also revealed that rhBMP-2-loaded ACS has a release of rhBMP-2 over 21 days with a half-life of 2 days The use of an alternative delivery system may retain and sequester rhBMPs at the target site and extend its growth factor release over time This may be clinically relevant as prolonging tissue exposure to an osteoinductive growth factor like rhBMP-2 could extend the period of osteoblastic bone deposition and improve repair at regenerative sites E-PRF as an autologous carrier for rhBMP-2 may be advantageous based on its resorption properties of up to 4-6 months as well as its ability to support the healing process due to the slow and gradual release of several growth factors including PDGF-AA PDGF-BB TGF- β1VEGF IGF and EGF This study aims to quantify the release of rhBMP-2 over a 120 day period with the use of a novel delivery system E-PRF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None