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

September 7, 2023 updated by: GID BIO, Inc.

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • California
      • Sacramento, California, United States, 95817
        • Enrolling by invitation
        • UC Davis
    • Florida
      • Coral Springs, Florida, United States, 33067
      • Orlando, Florida, United States, 32810
        • Withdrawn
        • Advent Health
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University
        • Contact:
        • Principal Investigator:
          • Jaime R Garza, MD
    • New Jersey
      • Cedar Knolls, New Jersey, United States, 07927
        • Enrolling by invitation
        • New Jersey Regenerative Institute
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Enrolling by invitation
        • OrthoCarolina Research Institute
      • Winston-Salem, North Carolina, United States, 27106
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Contact:
        • 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
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Active, not recruiting
        • Ohio State University Jameson Crane Sports Medicine Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • J. Peter Rubin, MD
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78240
        • Active, not recruiting
        • Texas Center for Cell Therapy and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 12 months
Summary of device, treatment and procedure related adverse event rates and severity
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: William Cimino, PhD, GID BIO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • GIDOA-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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