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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04440189
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Osteoarthritis, Knee Device: GID SVF-2 Device System Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 : October 15, 2020
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects will receive an injection of Lactated Ringers in their index knee
Device: GID SVF-2 Device System
The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.

Experimental: Stromal Vascular Fraction (SVF)
Subjects will receive an injection of Stromal Vascular Fraction in their index knee
Device: GID SVF-2 Device System
The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.




Primary Outcome Measures :
  1. Western Ontario and McMaster Universities Arthritis Index [ Time Frame: 6 months ]
    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 6 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.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 months ]
    Summary of device, treatment and procedure related adverse event rates and severity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440189


Contacts
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Contact: Amanda Lark 303-952-4901 ext 109 amanda.lark@gidbio.com

Locations
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United States, California
UC Davis Recruiting
Sacramento, California, United States, 95817
Contact: Colleen Anthonisen    916-734-4307    canthonisen@ucdavis.edu   
Contact: Erica Goude    9167340384    emgoude@ucdavis.edu   
Principal Investigator: Charles DeMesa, DO         
Sub-Investigator: Alyssa Speciale, MD         
Sub-Investigator: Kevin Mullins, MD         
Sub-Investigator: Brandee Waite, MD         
Sub-Investigator: Alberto Panero, DO         
United States, Florida
Advanced Research LLC Recruiting
Coral Springs, Florida, United States, 33067
Contact: Adriana Garcia Suji    954-204-0052    agarcia@advancedresearchfl.com   
Contact: Vivek Sawhney    954-204-0052    vsawhney@advancedresearchfl.com   
Principal Investigator: Manish Gupta, MD         
Advent Health Recruiting
Orlando, Florida, United States, 32810
Contact: Robin Barron, RN       robin.barron@adventhealh.com   
Contact: Cristina Santiago       cristina.santiago@adventhealth.com   
Principal Investigator: Tariq Awan, DO         
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Emily Callegari    504-988-0200    ctu@tulane.edu   
Principal Investigator: Jaime R Garza, MD         
United States, New Jersey
New Jersey Regenerative Institute Recruiting
Cedar Knolls, New Jersey, United States, 07927
Contact: Shalaka Paranjpe    973-998-8301    sparanjpe@kesslerfoundation.org   
Principal Investigator: Gerald Malanga, MD         
United States, North Carolina
OrthoCarolina Research Institute Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Caleb Michalek, CCRC    704-323-3698    caleb.michalek@orthocarolina.com   
Contact: Taylor Rowe    704-323-2261    taylor.rowe@orthocarolina.com   
Principal Investigator: Claude T Moorman, MD         
Sub-Investigator: Bryan Salzman, MD         
Sub-Investigator: David Matthews, MD         
Sub-Investigator: Michael Carstens, MD         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27106
Contact: Erica Hartzell    336-713-3824    ehartzel@wakehealth.edu   
Contact: Nina Cruz-Diaz    336.716.0824    nmcruzdi@wakehealth.edu   
Principal Investigator: Neil Sparks, DO         
Sub-Investigator: Adam Katz, MD         
Sub-Investigator: Brian Waterman, MD         
Sub-Investigator: Maxwell Langfitt, MD         
Sub-Investigator: Christopher Miles, MD         
Sub-Investigator: Heath Thornton, MD         
Sub-Investigator: Laura Linter, DO         
United States, Ohio
Ohio State University Jameson Crane Sports Medicine Institute Not yet recruiting
Columbus, Ohio, United States, 43202
Contact: Sarah Jia, BS    614-293-8250    liuqing.jia@osumc.edu   
Contact: Michael Keller       Michael.Keller@osumc.edu   
Principal Investigator: Michael Baria, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Anne Lindsey, BS    412-648-4318    lindseyal2@upmc.edu   
Contact: Eleanor Shirley, MA, CCRC    412-383-7712    shirleye@upmc.edu   
Principal Investigator: J. Peter Rubin, MD         
Sub-Investigator: Kentaro Onishi, MD         
United States, Texas
Texas Center for Cell Therapy and Research Recruiting
San Antonio, Texas, United States, 78240
Contact: Jennifer Krieger    210-616-0301    jkrieger@txps.net   
Principal Investigator: Jaime R Garza, MD         
Sponsors and Collaborators
GID BIO, Inc.
Investigators
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Study Chair: William Cimino, PhD GID BIO
Publications of Results:
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Responsible Party: GID BIO, Inc.
ClinicalTrials.gov Identifier: NCT04440189    
Other Study ID Numbers: GIDOA-03
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases