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NCT04964466 · ClinicalTrials.gov registry record
Release Kinetics in PRF Versus GEM21S With and Without Bone Substitutes: An In Vitro Analysis
A clinical trial of Bone Loss, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- 5
- Enrollment target
- 1
- Study location
NCT04964466 is a study of Bone Loss that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 5 participants, below the 254-participant average among 16 other Bone Loss trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04964466, a study of Bone Loss, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
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".
Conditions Studied
Interventions
- BIOLOGICAL 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
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2026-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04964466
The ClinicalTrials.gov registry entry for NCT04964466 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 254-participant average among 16 other Bone Loss trials with a reported enrollment target (98% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bone Loss appearing as the primary indexed condition, and to 4 interventions - of which Amount of PDGF-BB in PRF preparation vs. GEM21 is the first listed.
NCT04964466 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT04964466 about?
NCT04964466 is a clinical study titled "Release Kinetics in PRF Versus GEM21S With and Without Bone Substitutes: An In Vitro Analysis". 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 Fib...
What is the current status of trial NCT04964466?
This trial is currently active not recruiting. The enrollment target is 5 participants. The study started on 2021-08-31. Estimated completion is 2026-12.
What conditions does trial NCT04964466 study?
This clinical trial studies the following conditions: Bone Loss.
What interventions are being tested in trial NCT04964466?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT04964466?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04964466 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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