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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 : Completed
First Posted : April 4, 2016
Results First Posted : August 21, 2019
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
The GID Group

Tracking Information
First Submitted Date  ICMJE March 24, 2016
First Posted Date  ICMJE April 4, 2016
Results First Submitted Date  ICMJE May 29, 2019
Results First Posted Date  ICMJE August 21, 2019
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
Safety - Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]
Subjects will be monitored for adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
  • Efficacy - Change in Pain Scores on the WOMAC Scale at All Follow-up Visits [ Time Frame: 1 & 6 weeks, 3 & 6 months ]
    Patient outcomes for pain will be recorded
  • Efficacy - Change in Function Scores on the WOMAC Scale at All Follow-up Visits [ Time Frame: 1 & 6 weeks, 3 & 6 months ]
    Patient outcomes for function will be recorded
  • Efficacy - Change in Stiffness Scores on the WOMAC Scale at All Follow-up Visits [ Time Frame: 1 & 6 weeks, 3 & 6 months ]
    Patient outcomes for stiffness will be recorded
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adipose-derived SVF for the Treatment of Knee OA
Official Title  ICMJE Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Controlled, Randomized, Double-Blinded Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis (OA)
Intervention  ICMJE
  • 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.
  • Other: Placebo
    Placebo Control
Study Arms  ICMJE
  • Experimental: Low Dose SVF
    This group of subjects will receive a low dose of SVF for treatment of knee OA.
    Intervention: Device: GID SVF-2
  • Experimental: High Dose
    This group of subjects will receive a high dose of SVF for treatment of knee OA.
    Intervention: Device: GID SVF-2
  • Placebo Comparator: Placebo
    This group of subjects will receive a placebo with no SVF Cells for treatment of knee OA.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2016)
39
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02726945
Other Study ID Numbers  ICMJE GIDOA-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This study will report average demographics and WOMAC OA score. Individual adverse events may be reported.
Responsible Party The GID Group
Study Sponsor  ICMJE The GID Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Victoria Good, PhD The GID Group
PRS Account The GID Group
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP