- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440189
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sandeep Samudre, PhD, MPH
- Phone Number: 105 303-952-4901
- Email: s.samudre@gidbio.com
Study Locations
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California
-
Sacramento, California, United States, 95817
- Enrolling by invitation
- UC Davis
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Florida
-
Coral Springs, Florida, United States, 33067
- Recruiting
- Advanced Research LLC
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Contact:
- Vivek Sawhney
- Phone Number: 954-204-0052
- Email: vsawhney@advancedresearchfl.com
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Principal Investigator:
- Manish Gupta, MD
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Contact:
- Wafa Abdelaziz
- Phone Number: 954-302-3047
- Email: Wabdelaziz@advancedresearchfl.com
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Orlando, Florida, United States, 32810
- Withdrawn
- Advent Health
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Recruiting
- Tulane University
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Contact:
- Emily Callegari
- Phone Number: 504-988-0200
- Email: ctu@tulane.edu
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Principal Investigator:
- Jaime R Garza, MD
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New Jersey
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Cedar Knolls, New Jersey, United States, 07927
- Enrolling by invitation
- New Jersey Regenerative Institute
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Enrolling by invitation
- OrthoCarolina Research Institute
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Winston-Salem, North Carolina, United States, 27106
- Recruiting
- Wake Forest University Health Sciences
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Contact:
- Erica Hartzell
- Phone Number: 336-713-3824
- Email: ehartzel@wakehealth.edu
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Contact:
- Nina Cruz-Diaz
- Phone Number: 336.716.0824
- Email: nmcruzdi@wakehealth.edu
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Principal Investigator:
- Neil Sparks, DO
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Sub-Investigator:
- Adam Katz, MD
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Sub-Investigator:
- Brian Waterman, MD
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Sub-Investigator:
- Maxwell Langfitt, MD
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Sub-Investigator:
- Christopher Miles, MD
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Sub-Investigator:
- Heath Thornton, MD
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Sub-Investigator:
- Laura Linter, DO
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Ohio
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Columbus, Ohio, United States, 43202
- Active, not recruiting
- Ohio State University Jameson Crane Sports Medicine Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- Recruiting
- University of Pittsburgh Medical Center
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Contact:
- Eleanor Shirley, MA, CCRC
- Phone Number: 412-383-7712
- Email: shirleye@upmc.edu
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Principal Investigator:
- J. Peter Rubin, MD
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Contact:
- Eleanor Shirley, MA, CCRC
- Email: shirleye@upmc.edu
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Texas
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San Antonio, Texas, United States, 78240
- Active, not recruiting
- Texas Center for Cell Therapy and Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
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.
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Experimental: Stromal Vascular Fraction (SVF)
Subjects will receive an injection of Stromal Vascular Fraction in their index knee
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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
Sponsor
Investigators
- Study Chair: William Cimino, PhD, GID BIO
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIDOA-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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-
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