Clinical trial

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

Name

IRB-300005939

Description

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.

Trial arms

Trial start

2024-08-01

Estimated PCD

2025-12-01

Trial end

2026-12-01

Status

Not yet recruiting

Treatment

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.

Arms:

E-PRF/rhBMP-2 (similar ratios)

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.

Arms:

E-PRF/ACS/rhBMP-2

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

Arms:

rhBMP-2/E-PRF

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.

Arms:

E-PRF only

Size

Primary endpoint

To quantify any difference between test groups in the release of rhBMP-2 after application to E-PRF and ACS, E-PRF, and ACS.

From baseline to 6 months

Eligibility criteria

Inclusion Criteria: * English speaking * At least 18 years old * Must be a patient of the UAB Dental School * Able to read and understand informed consent document * Previously treatment planned for a periodontal procedure that will utilize PRF, i.e. requiring venipuncture, as a part of the routine clinical care. Exclusion Criteria: * Non-English speaking * Less than 18 years old * Smokers/tobacco users (\>10 cigarettes/day) * Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing as assessed by Board Certified Periodontal faculty at UAB Department of Periodontology * Patient-reported serious adverse events reported with venipuncture, blood sample collection, and/or blood donation.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood will be harvested to form L-PRF membranes, which will be used in in vitro clinical assessments.'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2023-12-18

1 organization

4 products

1 indication

Organization

University of Alabama at Birmingham

Product

Indication

Product

Product

Product