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临床试验/NCT04670965
NCT04670965尚未招募不适用

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

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
To quantify any difference between test groups in the release of rhBMP-2 after application to E-PRF and ACS, E-PRF, and ACS.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: E-PRF/rhBMP-2 (similar ratios) (Biological)

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.

干预措施: rhBMP-2/E-PRF (Biological)

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.

干预措施: E-PRF/ACS/rhBMP-2 (Biological)

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.

干预措施: E-PRF only (Biological)

结局指标

主要结局

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

时间窗: From baseline to 6 months

The quanitites of rhBMP-2 at all time points from all groups will be compared using statistical analysis by two-way ANOVA with Bonferroni test.

次要结局

  • To more assess the capability of E-PRF without added rhBMP-2 to release any intrinsic autologous BMP-2 under experimental conditions.(From baseline to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria L. Geisinger, DDS, MS

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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