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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04670965
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Bone Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • E-PRF/rhBMP-2 (similar ratios) — BIOLOGICAL
    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.
  • E-PRF/ACS/rhBMP-2 — BIOLOGICAL
    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.
  • rhBMP-2/E-PRF — BIOLOGICAL
    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
  • E-PRF only — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: E-PRF/rhBMP-2 (similar ratios)
    Subjects will be used to procure the venous blood samples to make the enhanced platelet rich fibrin (E-PRF). Subjects have an established treatment plan that utilizes autologous PRF as an adjunctive biologic therapy during periodontal treatment.
  • Arm: E-PRF/ACS/rhBMP-2
    Subjects will be used to procure the venous blood samples to make the enhanced platelet rich fibrin (E-PRF). Subjects have an established treatment plan that utilizes autologous PRF as an adjunctive biologic therapy during periodontal treatment.
  • Arm: rhBMP-2/E-PRF
    Subjects will be used to procure the venous blood samples to make the enhanced platelet rich fibrin (E-PRF). Subjects have an established treatment plan that utilizes autologous PRF as an adjunctive biologic therapy during periodontal treatment.
  • Arm: E-PRF only
    Subjects will be used to procure the venous blood samples to make the enhanced platelet rich fibrin (E-PRF). Subjects have an established treatment plan that utilizes autologous PRF as an adjunctive biologic therapy during periodontal treatment.

Primary Outcome Measure

To quantify any difference between test groups in the release of rhBMP-2 after application to E-PRF and ACS, E-PRF, and ACS. [ Time Frame: From baseline to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-0007-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, AL

Related Studies