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

NCT04440189 | Active Not Recruiting Phase 3 FDA Device

• 1 other identifier: GIDOA-03
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 9

Brief 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

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (1)

• Adverse Events

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will receive an injection of Lactated Ringers in their index knee

Device: GID SVF-2 Device System

Stromal Vascular Fraction (SVF)

EXPERIMENTAL

Subjects will receive an injection of Stromal Vascular Fraction in their index knee

Device: GID SVF-2 Device System

Interventions

GID SVF-2 Device System DEVICE

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

Placebo; Stromal Vascular Fraction (SVF)

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Subjects whose knee pain is caused by:
• i. 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
• 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

Sponsors & Collaborators

• GID BIO, Inc.: lead

Study Sites (9)

UC Davis

Sacramento, California, 95817, United States

Location

Advanced Research LLC

Coral Springs, Florida, 33067, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

New Jersey Regenerative Institute

Cedar Knolls, New Jersey, 07927, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27106, United States

Location

Ohio State University Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Texas Center for Cell Therapy and Research

San Antonio, Texas, 78240, United States

Location

Related Publications (1)

• 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.

  PMID: 32109160 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• William Cimino, PhD

  GID BIO

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: October 15, 2020
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)