Clinical trial NCT04670965: Release Kinetics of RhBMP-2 Using E-PRF As an Autologous Carrier: an in Vitro Analysis
Official title: Release Kinetics of RhBMP-2 Using E-PRF As an Autologous Carrier: an in Vitro Analysis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bone Loss
Keywords: Platelet concentrates
Platelet-rich fibrin
Growth factor
Bone morphogenic protein
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants must be at least 18 years old with demonstrated ability to understand and consent to the proposed study procedures. Subjects treated in the UAB School of Dentistry Periodontal Clinic and scheduled for procedures using platelet rich fibrin (PRF) were performed.

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 outcomes/healing 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 treatments.2-6 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- β1,VEGF, 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.

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.

Primary outcomes:
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.
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: To more assess the capability of E-PRF without added rhBMP-2 to release any intrinsic autologous BMP-2 under experimental conditions.
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Maria Geisinger, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: