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

• ClinicalTrials.gov Identifier: NCT04440189
• Recruitment Status: Recruiting
• First Posted: June 19, 2020
• Last Update Posted: June 1, 2022
• Sponsor: GID BIO, Inc.
• Information provided by (Responsible Party): GID BIO, Inc.

Study Description

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).

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Study Chair: William Cimino, PhD; GID BIO

More Information

Publications of Results:

Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. Am J Sports Med. 2020 Mar;48(3):588-598. doi: 10.1177/0363546519899923.

• Responsible Party: GID BIO, Inc.
• ClinicalTrials.gov Identifier: NCT04440189
• Other Study ID Numbers: GIDOA-03
• First Posted: June 19, 2020
• Last Update Posted: June 1, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases