Release Kinetics in PRF Versus GEM21S With and Without Bone Substitutes: An In Vitro Analysis (NCT04964466)
Growth Factor Availability and Release Kinetics in PRF Versus GEM21S With and Without Bone Substitutes: An In Vitro Analysis
🩺 Plain-English Summary (8th-Grade Level)
This study is seeking to evaluate that platelet-derived growth factor-BB (PDGF-BB) is a proven wound healing and osteogenic protein that plays a critical role in wound healing and previous research has demonstrated a non-linear response where higher dosages produced less effect. As Platelet Rich Fibrin (PRF) contains numerous platelets, it contains PDGF-BB, but at levels lower than in the commercially available product and with inter-individual variation, GEM21S. To achieve both ideal handling and achieve ideal levels of PDGF-BB, there is a rationale to add GEM 21S recombinant human platelet-derived growth factor-BB (rhPDGF) to a bone graft prior to making "sticky bone".
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years to 99 Years
🧪 Interventions in This Study
- Amount of PDGF-BB in PRF preparation vs. GEM21 (BIOLOGICAL)
- Amount of PDGF-BB available in PRF + bone substitutes vs. rhPDGF-BB+ bone substitutes following preparation (BIOLOGICAL)
- Release kinetics of PDGF-BB in PRF + bone substitutes vs. rhPDGF-BB + bone substitutes (BIOLOGICAL)
- Release kinetics of PDGF-BB in rhPDGF-BB + PRF + bone substitutes (BIOLOGICAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.