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Trial record 1 of 1 for:    GID | Osteoarthritis, Knee | United States
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Adipose-derived SVF for the Treatment of Knee OA

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02726945
Recruitment Status : Active, not recruiting
First Posted : April 4, 2016
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
The GID Group

Brief Summary:
This is a pivotal study. The study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for pain, function and stiffness in the knees of osteoarthritic subjects.

Condition or disease Intervention/treatment Phase
Osteoarthritis (OA) Device: GID SVF-2 Other: Placebo Not Applicable

Detailed Description:

Osteoarthritis is the main form of arthritis and affects over 20 million people in the United States. In the knee it can cause severe pain, reduced functionality and increased stiffness thus, a treatment that would reduce pain, increase function and reduce stiffness would be of benefit to many people.

This study will collect and disassociate adipose tissue and inject the stromal vascular fraction into the knee of the same patient. The study is controlled, randomized and double-blinded with 2 SVF treatments (high and low dose) and a placebo control.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Controlled, Randomized, Double-Blinded Trial
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 1, 2018
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Low Dose SVF
This group of subjects will receive a low dose of SVF for treatment of knee OA.
Device: GID SVF-2
The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain associated with joint osteoarthritis.

Experimental: High Dose
This group of subjects will receive a high dose of SVF for treatment of knee OA.
Device: GID SVF-2
The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain associated with joint osteoarthritis.

Placebo Comparator: Placebo
This group of subjects will receive a placebo with no SVF Cells for treatment of knee OA.
Other: Placebo
Placebo Control




Primary Outcome Measures :
  1. Safety - Number of Participants With Treatment-Emergent Serious Adverse Events [ Time Frame: up to 1 year ]
    Subjects will be monitored for serious and device related adverse events. Baseline MRIs will be compared to 1 year for any abnormal findings.


Secondary Outcome Measures :
  1. Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 6 Months [ Time Frame: baseline and 6 months ]

    The primary efficacy will be achieved if either dose group is shown to be superior to the placebo group at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable.

    The WOMAC score consists of 3 subscales, pain, stiffness and function. The overall score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis.




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI.
  • Study Subjects must have failed a minimum of at least two conservative therapies, spanning a period of at least 3 months.
  • 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.
  • Subjects will be in good health (ASA Class I-II) with a BMI < 35.
  • Subjects must have continued pain in the knee despite conservative therapies for at least 3 months.
  • Subjects with unilateral disease must present with symptomatic knee pain using the WOMAC subscale for pain.
  • Subjects must speak, read and understand English.
  • Subjects must be reasonably able to return for multiple follow-up visits.

Exclusion Criteria:

  • Subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans.
  • Subjects who have had surgery of either knee within 6 months prior to the screening visit.
  • Subjects who have had a major injury to the targeted knee within 12 months prior to enrolling in the study.
  • Subjects who have had an injection in either knee in the prior 3 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP).
  • 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 who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee.
  • Subjects that are unwilling to stop taking prescription or over the counter pain medication for 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 prior to injection.
  • Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis.
  • Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
  • Subjects that use any form of tobacco
  • 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 of the targeted/treatment 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): NCT02726945


Locations
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United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Rothman Institute
Egg Harbor Township, New Jersey, United States, 08234
United States, Texas
Texas Plastic Surgery
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
The GID Group
Investigators
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Study Director: Victoria Good, PhD The GID Group
  Study Documents (Full-Text)

Documents provided by The GID Group:

Publications:
Garza GR, Palomera T, Dumanian GA and Dos-Anjos S. Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Feasibility and Safety study. J Regen Med. 2015;4(1)

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Responsible Party: The GID Group
ClinicalTrials.gov Identifier: NCT02726945    
Other Study ID Numbers: GIDOA-01
First Posted: April 4, 2016    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study will report average demographics and WOMAC OA score. Individual adverse events may be reported.
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases