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NCT04440189 | RECRUITING | Osteoarthritis, Knee

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

GID BIO, Inc.

Brief Summary:

This study 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.

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

GID SVF-2 Device System

Phase

NA

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 124 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2020-10-15
Estimated Primary Completion Date : 2023-12-30
Estimated Study Completion Date : 2024-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. 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 2.5 cm in any direction
  • 2. Kellgren and Lawrence score grade 2-4 as diagnosed on X-Ray
  • 3. Index knee must present with a score ≥8 using the WOMAC pain scale (A1 subscale, 20 total points)
  • 4. 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
  • 5. Males and females 35-85 years old
  • 6. Subjects with BMI ≥22 and ≤ 37
  • 7. Subjects must speak, read and understand English
  • 8. Subjects must be able to return for multiple follow-up visits
  • 9. 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
    • 1. Physical Therapy: 6 week course of treatment
    • 2. Exercise Therapy: 6 week course of treatment
    • 3. Viscosupplementation injection in the knee for OA pain
    • 4. Steroid injection in the knee for OA pain
    • 5. Platelet-Rich Plasma (PRP) injection in the knee for OA pain
    • 6. Arthroscopic surgery including microfracture and/or debridement
    • 7. Braces or other support devices: therapy tried for at least 2 weeks
    • 8. Over the Counter (OTC) pain medication including NSAIDS, Acetaminophen, ASA: therapy tried for at least 2 weeks
    • 9. Prescription pain medication: therapy tried for at least 1 weeks
    • 10. Modification of Activities of Daily Living (ADL): therapy tried for at least 2 weeks
    • 11. Topical applications to the knee for OA pain: therapy tried for at least 2 weeks
    • 12. Supplements including glucosamine sulfate and chondroitin sulfate: therapy tried for at least 4 weeks
    • 13. Ice/Heat regimen: therapy tried for at least 2 weeks
    Exclusion Criteria
    • 1. 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
      • 2. Outerbridge Scale Grade 0-I as diagnosed on MRI
      • 3. Outerbridge Scale Grade IV where the full thickness lesion of the articular cartilage is greater than 2.5 cm in any direction, as diagnosed on MRI
      • 4. Subjects with malignant neoplasms of the bone, cartilage, synovium or vasculature.
      • 5. Subjects who have had surgery of either knee within 6 months prior to the surgery visit
      • 6. Subjects who have had a major injury to either knee within 12 months prior to the surgery visit
      • 7. 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
      • 8. Subjects who have a diagnosis of gout with a flare in the past 12 months.
      • 9. Subjects who have a diagnosis of Pes Anserine Bursitis with an event in the past 12 months.
      • 10. Subjects who have had a diagnosed infection in the knee joint in the past 12 months.
      • 11. 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
      • 12. Diagnosis of severe bone deformity defined as greater than 10 degrees of either varus or valgus deformity
      • 13. 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).
      • 14. Subjects that are allergic to lidocaine, epinephrine or valium
      • 15. 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
      • 16. Subjects with systemic immunosuppressant use within 6 weeks from screening
      • 17. Subjects with HIV or viral hepatitis
      • 18. Subjects who have ever received a diagnosis of
        • chondrocalcinosis, Paget's disease or Villonodular synovitis
        • 19. Subjects that use any form of tobacco, including e-cigarettes, more than once a week over the most recent 1 year period
        • 20. Women that are pregnant or planning to become pregnant during the study
        • 21. Subjects on long term oral steroids defined as longer than a 2-week taper.
        • 22. History of any chemotherapy or radiation therapy on either leg or adipose harvest site
        • 23. Subjects currently on workers' compensation
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis

Location Details

NCT04440189

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

ENROLLING BY INVITATION

United States, California

UC Davis

Sacramento, California, United States, 95817

RECRUITING

United States, Florida

Advanced Research LLC

Coral Springs, Florida, United States, 33067

WITHDRAWN

United States, Florida

Advent Health

Orlando, Florida, United States, 32810

RECRUITING

United States, Louisiana

Tulane University

New Orleans, Louisiana, United States, 70112

ENROLLING BY INVITATION

United States, New Jersey

New Jersey Regenerative Institute

Cedar Knolls, New Jersey, United States, 07927

ENROLLING BY INVITATION

United States, North Carolina

OrthoCarolina Research Institute

Charlotte, North Carolina, United States, 28207

RECRUITING

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27106

ACTIVE NOT RECRUITING

United States, Ohio

Ohio State University Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States, 43202

RECRUITING

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15261

ACTIVE NOT RECRUITING

United States, Texas

Texas Center for Cell Therapy and Research

Saint Anthony, Texas, United States, 78240