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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 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 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (80% lower). The trial reports 9 study locations across 8 states.

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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.

Conditions Studied

Osteoarthritis, Knee

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

FieldValue
Enrollment Target 114 participants
Start Date 2020-10-15
Est. Completion 2025-06-30
Phase Phase 3

Sponsor

GID BIO

3 total trials

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What the Registry Record Tells You About NCT04440189

The ClinicalTrials.gov registry entry for NCT04440189 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (80% lower). The listed sponsor is GID BIO, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.