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

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ClinicalTrials.gov Identifier: NCT04440189
Recruitment Status : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : August 31, 2020
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
Estimated Study Start Date : November 30, 2020
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : November 30, 2022

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

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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:

  • 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 1.5 cm in any direction
  • 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

Exclusion Criteria:

  • Subjects whose knee pain is caused by:
  • unstable meniscal root tears or locked bucket handle meniscal tears
  • displaced meniscus tear
  • full thickness lesion of the articular cartilage greater than 1.5 cm in any direction
  • osteo chondritis dissecans
  • parameniscal, Baker's, or ganglion cysts
  • lipoma arborescens
  • Hoffa's Pad Syndrome
  • acute ligament tears
  • diffuse edema
  • pain due to patellar mal-tracking or patellar dislocations
  • Outerbridge Scale Grade I as diagnosed on MRI
  • Outerbridge Scale Grade IV where the full thickness lesion of the articular cartilage is greater than 1.5 cm in any direction, as diagnosed on MRI
  • 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 in 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 gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication
  • Subjects that are unwilling to stop taking prescription or over the counter pain medication 7 days prior to any 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, Xeralta® (rivaroxaban) for 24 hours
  • Subjects with systemic immunosuppressant use within 6 weeks from screening and subjects with HIV or viral hepatitis
  • Subjects with 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 use of oral steroids
  • History of any chemotherapy or radiation therapy on either leg or adipose harvest site
  • Subjects currently on worker's 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: Abigail Lowe 3039524901 ext 109 a.lowe@gidbio.com
Contact: Victoria Good, PhD 3039524901 ext 106 vgood@gidbio.com

Locations
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United States, Louisiana
Tulane University
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
Cedar Knolls, New Jersey, United States, 07927
Contact: Shalaka Paranjpe    973-998-8301    sparanjpe@kesslerfoundation.org   
Principal Investigator: Gerald Malanga, MD         
United States, Texas
Texas Center for Cell Therapy and Research
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: August 31, 2020
Last Verified: June 2020
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