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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: Active study of Bone Loss, sponsored by University of Alabama at Birmingham.
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. According to ClinicalTrials.gov, the official US trial registry.
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".
Primary Outcome
The quantities of PDGF-BB statistical analysis using a two-way analysis of variance for the proliferation assay with Bonferroni test.
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 |
What the registry record for NCT04964466 still lists
NCT04964466 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 254-participant average among 16 other Bone Loss trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Bone Loss
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04964466's enrollment target sits among peer trials
5 17th of 16 the lowest of 16 other Bone Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bone Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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