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Osteoarthritis, KneePhase 3NCT04440189

Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis

A Phase 3 study testing GID SVF-2 Device System in people with Osteoarthritis, Knee, run by GID BIO, Inc. at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 85 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
GID SVF-2 Device System
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
9 sitesUnited States
Study dates
15 Oct 2020to 30 Jun 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Bilateral or unilateral knee osteoarthritis as diagnosed on pre-op MRI using the Outerbridge Cartilage Classification as Grade II, Grade III, or Grade IV with full thickness lesion of the articular cartilage is less than 4.0 cm in any direction
  • Kellgren and Lawrence score grade 2-4 as diagnosed on X-Ray
  • Index knee must present with a score ≥8 using the WOMAC pain scale (A1 subscale, 20 total points)
  • Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed
  • Males and females 35-85 years old
  • Subjects with BMI ≥22 and ≤ 37
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  • Subjects must speak, read and understand English
  • Subjects must be able to return for multiple follow-up visits
  • Subjects must have failed at least two conservative therapies for treatment of knee OA within the last 24 months (2 years), with one or more of the failed conservative therapies being from a-f:
  • Physical Therapy: 6 week course of treatment
  • Exercise Therapy: 6 week course of treatment
  • Viscosupplementation injection in the knee for OA pain
  • Steroid injection in the knee for OA pain
  • Platelet-Rich Plasma (PRP) injection in the knee for OA pain
  • Arthroscopic surgery including microfracture and/or debridement
  • Braces or other support devices: therapy tried for at least 2 weeks
  • Over the Counter (OTC) pain medication including NSAIDS, Acetaminophen, ASA: therapy tried for at least 2 weeks
  • Prescription pain medication: therapy tried for at least 1 weeks
  • Modification of Activities of Daily Living (ADL): therapy tried for at least 2 weeks
  • Topical applications to the knee for OA pain: therapy tried for at least 2 weeks
  • Supplements including glucosamine sulfate and chondroitin sulfate: therapy tried for at least 4 weeks
  • Ice/Heat regimen: therapy tried for at least 2 weeks

Who cannot join

  • Subjects whose knee pain is caused by:
  • unstable meniscal root tears or locked bucket handle meniscal tears ii. displaced meniscus tear iii. osteo chondritis dissecans iv. parameniscal, Baker's, or ganglion cysts v. lipoma arborescens vi. Hoffa's Pad Syndrome vii. acute ligament tears viii. diffuse edema ix. patellar mal-tracking or patellar dislocations
  • Outerbridge Scale Grade 0-I as diagnosed on MRI
  • Outerbridge Scale Grade IV where the full thickness lesion of the articular cartilage is greater than 4.0 cm in any direction, as diagnosed on MRI
  • Subjects with malignant neoplasms of the bone, cartilage, synovium or vasculature.
  • Subjects who have had surgery of either knee within 6 months prior to the surgery visit
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  • Subjects who have had a major injury to either knee within 12 months prior to the surgery visit
  • Subjects who have had an injection into the intraarticular space of either knee in the prior 6 months, including corticosteroids, viscosupplementation, stromal vascular fraction (SVF), bone marrow stem cells, or platelet rich plasma
  • Subjects who have a diagnosis of gout with a flare in the past 12 months.
  • Subjects who have a diagnosis of Pes Anserine Bursitis with an event in the past 12 months.
  • Subjects who have had a diagnosed infection in the knee joint in the past 12 months.
  • Subject who have received a diagnosis of the following at any time: rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, fibromyalgia, or neurogenic or vascular claudication
  • Diagnosis of severe bone deformity defined as greater than 10 degrees of either varus or valgus deformity
  • Subjects that are unwilling to stop taking prescription or over the counter pain medication 7 days prior to any visit (except Day 2 Post Treatment Visit).
  • Subjects that are allergic to lidocaine, epinephrine or valium
  • Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (colpidogrel) for 3 days, ASA/NSAIDs/fish oil supplements for 7 days, Xarelto® (rivaroxaban) for 24 hours
  • Subjects with systemic immunosuppressant use within 6 weeks from screening
  • Subjects with HIV or viral hepatitis
  • Subjects who have ever received a diagnosis of:
  • chondrocalcinosis, Paget's disease or Villonodular synovitis
  • Subjects that use any form of tobacco, including e-cigarettes, more than once a week over the most recent 1 year period
  • Women that are pregnant or planning to become pregnant during the study
  • Subjects on long term oral steroids defined as longer than a 2-week taper.
  • History of any chemotherapy or radiation therapy on either leg or adipose harvest site
  • Subjects currently on workers' compensation

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • New Jersey Regenerative Institute

    Cedar Knolls, New Jersey, 07927

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207

  • Ohio State University Jameson Crane Sports Medicine Institute

    Columbus, Ohio, 43202

  • Advanced Research LLC

    Coral Springs, Florida, 33067

  • Tulane University

    New Orleans, Louisiana, 70112

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261

  • UC Davis

    Sacramento, California, 95817

  • Texas Center for Cell Therapy and Research

    San Antonio, Texas, 78240

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27106

Other trials in United States

About this study

Official title: Use of GID SVF-2 Device to Produce Autologous Adipose-Derived Stromal Vascular Fraction for Treatment of Osteoarthritis of the Knee: A Pivotal Medical Device Randomized Concurrent Controlled Study

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.

Read the detailed description

This is a prospective, randomized, placebo controlled, parallel groups, double blind, multi-center, interventional study of subjects with osteoarthritis of the knee. Subjects will be randomized to receive an injection of LR (placebo) or SVF derived from their own adipose tissue (experimental).

Being tested
GID SVF-2 Device System
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GID SVF-2 Device SystemDevice

    The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.

Study groups in NCT04440189
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubjects will receive an injection of Lactated Ringers in their index knee
Receives: Device: GID SVF-2 Device System
Stromal Vascular Fraction (SVF)ExperimentalSubjects will receive an injection of Stromal Vascular Fraction in their index knee
Receives: Device: GID SVF-2 Device System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Western Ontario and McMaster Universities Arthritis Index

    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.

    Measured: 12 months

Secondary outcomes (1)

  1. Adverse Events

    Summary of device, treatment and procedure related adverse event rates and severity

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2020
  2. Study start15 Oct 2020
  3. Primary completion30 Dec 2024
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04440189
Sponsor's protocol ID
GIDOA-03
Status last verified
Apr 2025
First submitted
17 Jun 2020
Last updated
23 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. Am J Sports Med. 2020 Mar;48(3):588-598. doi: 10.1177/0363546519899923.

    PubMed 32109160

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GID SVF-2 Device System in people with Osteoarthritis, Knee, run by GID BIO, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Western Ontario and McMaster Universities Arthritis Index (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04440189, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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