Release Kinetics of rhBMP-2 Using E-PRF as an Autologous Carrier: An In Vitro Analysis

Not yet recruitingOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

July 31, 2027

Conditions
Bone Loss
Interventions
BIOLOGICAL

E-PRF/rhBMP-2 (similar ratios)

During its preparation, 1.5 mg/ml rhBMP-2 will be incorporated into standardized samples to assure similar E-PRF to rhBMP-2 ratios. To allow for consistency across all samples, standardized E-PRF volume will be established using formation templates. Following its preparation, the E-PRF/rhBMP2 scaffold will undergo a standard in vitro assay to investigate growth factor release over time (ELISA quantification assay). Briefly, the e-PRF/rhBMP2 scaffold will be placed in a shaking incubator at 37 degree Celsius and assessed for growth factor release of rhBMP-2 over time.

BIOLOGICAL

E-PRF/ACS/rhBMP-2

rhBMP-2 diluted to account for the additional volume from the E-PRF in other samples will be loaded onto lyophilized absorbable collagen sponges as per the package insert. After the addition of the rhBMP-2, the ACS will be cut into 2mm x 2mm pieces and incorporated into the E-PRF membrane. Following its preparation, rhBMP-2 release from the E-PRF/ACS/rhBMP2 scaffold will be quantified using the ELISA quantification assay as described above.

BIOLOGICAL

rhBMP-2/E-PRF

rhBMP-2 diluted to account for the additional volume from the E-PRF in other samples will be loaded onto lyophilized absorbable collagen sponges as per the package insert. Rh-BMP2 release will be quantified using the ELISA quantification assay as described above

BIOLOGICAL

E-PRF only

E-PRF will be prepared and standardized, but no rhBMP-2 will be added to the material. After preparation, the E-PRF scaffold assayed via ELISA quantification assay as described above to determine the release (if any) of intrinsic BMP-2 from the platelet concentrate scaffold.

Trial Locations (1)

35294-0007

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER

NCT04670965 - Release Kinetics of rhBMP-2 Using E-PRF as an Autologous Carrier: An In Vitro Analysis | Biotech Hunter | Biotech Hunter