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

StatusWithdrawn
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Stopped Withdrawn before enrolling Sponsor's reason: The study was stopped due to the funding issues. Enrollment target: estimated 20 to confirmed 0 · Interventions: E-PRF only (Biological), E-PRF/ACS/rhBMP-2 (Biological), E-PRF/rhBMP-2 (similar ratios) (Biological), rhBMP-2/E-PRF (Biological) to E-PRF only (Biological), E-PRF/ACS/rhBMP-2 (Biological), E-PRF/rhBMP-2 (similar ratios) (Biological), rhBMP-2/E-PRF (Biological) · Eligibility criteria expanded, about 10 words Show 3 more changesShow less
    • Enrollment target: estimated 20 to confirmed 0
    • Interventions: E-PRF only (Biological), E-PRF/ACS/rhBMP-2 (Biological), E-PRF/rhBMP-2 (similar ratios) (Biological), rhBMP-2/E-PRF (Biological) to E-PRF only (Biological), E-PRF/ACS/rhBMP-2 (Biological), E-PRF/rhBMP-2 (similar ratios) (Biological), rhBMP-2/E-PRF (Biological)
    • Eligibility criteria expanded, about 10 words
  2. Notable Start date: Apr 2026 to Sep 2026v16
  3. Notable Primary completion date: Dec 2026 to Dec 2027 Start date: Dec 2025 to Apr 2026 · Completion date: Jul 2027 to Jul 2028v15 Show 2 more changesShow less
    • Start date: Dec 2025 to Apr 2026
    • Completion date: Jul 2027 to Jul 2028
  4. Notable Start date: Aug 2025 to Dec 2025 Primary completion date: Aug 2026 to Dec 2026 · Completion date: Feb 2027 to Jul 2027v14 Show 2 more changesShow less
    • Primary completion date: Aug 2026 to Dec 2026
    • Completion date: Feb 2027 to Jul 2027
  5. Notable Start date: Feb 2025 to Aug 2025 Primary completion date: Feb 2026 to Aug 2026v13 Show 1 more changeShow less
    • Primary completion date: Feb 2026 to Aug 2026
Show 11 earlier versionsHide 11 earlier versions
  1. Notable Start date: Dec 2024 to Feb 2025 Primary completion date: Dec 2025 to Feb 2026 · Completion date: Dec 2026 to Feb 2027v12 Show 2 more changesShow less
    • Primary completion date: Dec 2025 to Feb 2026
    • Completion date: Dec 2026 to Feb 2027
  2. Notable Start date: Aug 2024 to Dec 2024v11
  3. Notable Primary completion date: Dec 2024 to Dec 2025 Start date: Dec 2023 to Aug 2024 · Completion date: Dec 2025 to Dec 2026v10 Show 2 more changesShow less
    • Start date: Dec 2023 to Aug 2024
    • Completion date: Dec 2025 to Dec 2026
  4. Minor Re-verified, no change to tracked fieldsv9
  5. Notable Primary completion date: Dec 2023 to Dec 2024 Start date: Aug 2022 to Dec 2023 · Completion date: Dec 2024 to Dec 2025v8 Show 2 more changesShow less
    • Start date: Aug 2022 to Dec 2023
    • Completion date: Dec 2024 to Dec 2025
  6. Notable Primary completion date: Dec 2022 to Dec 2023 Start date: Feb 2022 to Aug 2022 · Completion date: Jan 2023 to Dec 2024v7 Show 2 more changesShow less
    • Start date: Feb 2022 to Aug 2022
    • Completion date: Jan 2023 to Dec 2024
  7. Notable Primary completion date: Dec 2021 to Dec 2022 Start date: Dec 2021 to Feb 2022 · Completion date: Jan 2022 to Jan 2023v6 Show 2 more changesShow less
    • Start date: Dec 2021 to Feb 2022
    • Completion date: Jan 2022 to Jan 2023
  8. Notable Start date: Sep 2021 to Dec 2021v5
  9. Notable Start date: Jun 2021 to Sep 2021v4
  10. Notable Start date: Feb 2021 to Jun 2021v3
  11. Minor Start date: Jan 2021 to Feb 2021 Study description revisedv2 Show 1 more changeShow less
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04670965
Lead Sponsor University of Alabama at Birmingham
Conditions Bone Loss
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov