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NCT04440189 · ClinicalTrials.gov registry record · Phase 3
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis
A Phase 3 study of Osteoarthritis, Knee, sponsored by GID BIO.
- Active
- Registry status
- Phase 3
- Development phase
- 114
- Enrollment target
- 9
- Study locations
NCT04440189: Active Phase 3 study of Osteoarthritis, Knee, sponsored by GID BIO.
NCT04440189 is a Phase 3 study of Osteoarthritis, Knee that is active but no longer recruiting, run by GID BIO. The registered enrollment target is 114 participants, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (77% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04440189, a Phase 3 study of Osteoarthritis, Knee, is active but no longer recruiting, sponsored by GID BIO.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 114 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.
Primary Outcome
The WOMAC is a self-administered questionnaire consisting of 14 items divided into 3 subscales, pain, stiffness and function. The primary efficacy will be achieved if the SVF dose group is shown to have a clinically meaningful improvement in pain and function at 12 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable. The overall WOMAC score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis.
Conditions Studied
Interventions
- DEVICE GID SVF-2 Device System
Study Locations (9)
North Carolina
- OrthoCarolina Research Institute - Charlotte
- Wake Forest University Health Sciences - Winston-Salem
California
- UC Davis - Sacramento
Florida
- Advanced Research LLC - Coral Springs
Louisiana
- Tulane University - New Orleans
New Jersey
- New Jersey Regenerative Institute - Cedar Knolls
Ohio
- Ohio State University Jameson Crane Sports Medicine Institute - Columbus
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Texas
- Texas Center for Cell Therapy and Research - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2020-10-15 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 3 |
What the registry record for NCT04440189 still lists
NCT04440189 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 1 intervention - of which GID SVF-2 Device System is the first listed.
NCT04440189 lists 9 locations in 8 states (North Carolina, California, Florida).
Frequently Asked Questions
What is clinical trial NCT04440189 about?
NCT04440189 is a clinical study titled "Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis". This is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.
What is the current status of trial NCT04440189?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2020-10-15. Estimated completion is 2025-06-30.
What conditions does trial NCT04440189 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT04440189?
The interventions under investigation include: GID SVF-2 Device System (DEVICE).
Who is sponsoring clinical trial NCT04440189?
This trial is sponsored by GID BIO, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04440189 being conducted?
This trial has 9 study locations across California, Florida, Louisiana, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
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 NCT04440189's enrollment target sits among peer trials
114 60th of 112 higher than 52 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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