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

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GID SVF-2 Device System
Sponsored by
GID BIO, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UC Davis
  • Advanced Research LLCRecruiting
  • Advent Health
  • Tulane UniversityRecruiting
  • New Jersey Regenerative Institute
  • OrthoCarolina Research Institute
  • Wake Forest University Health SciencesRecruiting
  • Ohio State University Jameson Crane Sports Medicine Institute
  • University of Pittsburgh Medical CenterRecruiting
  • Texas Center for Cell Therapy and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Stromal Vascular Fraction (SVF)

Arm Description

Subjects will receive an injection of Lactated Ringers in their index knee

Subjects will receive an injection of Stromal Vascular Fraction in their index knee

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Arthritis Index
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

Adverse Events
Summary of device, treatment and procedure related adverse event rates and severity

Full Information

First Posted
June 17, 2020
Last Updated
September 7, 2023
Sponsor
GID BIO, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04440189
Brief Title
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GID BIO, Inc.

4. Oversight

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

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive an injection of Lactated Ringers in their index knee
Arm Title
Stromal Vascular Fraction (SVF)
Arm Type
Experimental
Arm Description
Subjects will receive an injection of Stromal Vascular Fraction in their index knee
Intervention Type
Device
Intervention Name(s)
GID SVF-2 Device System
Intervention Description
The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Arthritis Index
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Summary of device, treatment and procedure related adverse event rates and severity
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 2.5 cm in any direction Kellgren and Lawrence score grade 2-4 as diagnosed on X-Ray 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 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: Physical Therapy: 6 week course of treatment Exercise Therapy: 6 week course of treatment Viscosupplementation injection in the knee for OA pain Steroid injection in the knee for OA pain Platelet-Rich Plasma (PRP) injection in the knee for OA pain Arthroscopic surgery including microfracture and/or debridement Braces or other support devices: therapy tried for at least 2 weeks Over the Counter (OTC) pain medication including NSAIDS, Acetaminophen, ASA: therapy tried for at least 2 weeks Prescription pain medication: therapy tried for at least 1 weeks Modification of Activities of Daily Living (ADL): therapy tried for at least 2 weeks Topical applications to the knee for OA pain: therapy tried for at least 2 weeks Supplements including glucosamine sulfate and chondroitin sulfate: therapy tried for at least 4 weeks Ice/Heat regimen: therapy tried for at least 2 weeks Exclusion Criteria: 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 Outerbridge Scale Grade 0-I as diagnosed on MRI 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 Subjects with malignant neoplasms of the bone, cartilage, synovium or vasculature. 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 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 Subjects who have a diagnosis of gout with a flare in the past 12 months. Subjects who have a diagnosis of Pes Anserine Bursitis with an event in the past 12 months. Subjects who have had a diagnosed infection in the knee joint in the past 12 months. 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 Diagnosis of severe bone deformity defined as greater than 10 degrees of either varus or valgus deformity 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). 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, Xarelto® (rivaroxaban) for 24 hours Subjects with systemic immunosuppressant use within 6 weeks from screening Subjects with HIV or viral hepatitis Subjects who have ever received a diagnosis of: 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 oral steroids defined as longer than a 2-week taper. History of any chemotherapy or radiation therapy on either leg or adipose harvest site Subjects currently on workers' compensation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandeep Samudre, PhD, MPH
Phone
303-952-4901
Ext
105
Email
s.samudre@gidbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Cimino, PhD
Organizational Affiliation
GID BIO
Official's Role
Study Chair
Facility Information:
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
Advanced Research LLC
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wafa Abdelaziz
Phone
954-302-3047
Email
Wabdelaziz@advancedresearchfl.com
First Name & Middle Initial & Last Name & Degree
Vivek Sawhney
Phone
954-204-0052
Email
vsawhney@advancedresearchfl.com
First Name & Middle Initial & Last Name & Degree
Manish Gupta, MD
Facility Name
Advent Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Individual Site Status
Withdrawn
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Callegari
Phone
504-988-0200
Email
ctu@tulane.edu
First Name & Middle Initial & Last Name & Degree
Jaime R Garza, MD
Facility Name
New Jersey Regenerative Institute
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
OrthoCarolina Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Hartzell
Phone
336-713-3824
Email
ehartzel@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Nina Cruz-Diaz
Phone
336.716.0824
Email
nmcruzdi@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Neil Sparks, DO
First Name & Middle Initial & Last Name & Degree
Adam Katz, MD
First Name & Middle Initial & Last Name & Degree
Brian Waterman, MD
First Name & Middle Initial & Last Name & Degree
Maxwell Langfitt, MD
First Name & Middle Initial & Last Name & Degree
Christopher Miles, MD
First Name & Middle Initial & Last Name & Degree
Heath Thornton, MD
First Name & Middle Initial & Last Name & Degree
Laura Linter, DO
Facility Name
Ohio State University Jameson Crane Sports Medicine Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleanor Shirley, MA, CCRC
Phone
412-383-7712
Email
shirleye@upmc.edu
First Name & Middle Initial & Last Name & Degree
Eleanor Shirley, MA, CCRC
Email
shirleye@upmc.edu
First Name & Middle Initial & Last Name & Degree
J. Peter Rubin, MD
Facility Name
Texas Center for Cell Therapy and Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32109160
Citation
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.
Results Reference
result

Learn more about this trial

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

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