Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 21 - 80 |
Updated: | 9/2/2018 |
Start Date: | November 2016 |
End Date: | June 2019 |
A Multicenter, Double-Blind, Randomized, Saline-Controlled Study of a Single, Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis
A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the
efficacy of a single dose of Autologous Protein Solution (APS) in patients with
Osteoarthritis (OA) of the knee.
efficacy of a single dose of Autologous Protein Solution (APS) in patients with
Osteoarthritis (OA) of the knee.
A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the
efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic
osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with
prior treatment.
efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic
osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with
prior treatment.
Inclusion Criteria:
- Male or female ≥ 21 and ≤ 80 years old at the time of screening
- Willingness and ability to comply with the study procedures and visit schedules and
ability to follow oral and written instructions
- A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 and an
absence of severe osteoarthritis
- Body Mass Index ≤ 40
- A qualifying WOMAC LK 3.1 pain subscale total score
- Has undergone at least one prior conservative osteoarthritis treatment
- Signed an institutional review board approved informed consent
Exclusion Criteria:
- Presence of clinically observed active infection in the index knee
- Presence of symptomatic osteoarthritis in the non-study knee
- Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout,
ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV,
viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis
- Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or
planned chemotherapeutic treatment
- Untreated symptomatic injury of the index knee
- Presence of surgical hardware or other foreign body intended to treat arthritis or
cartilage-related pathology in the index knee
- Previous cartilage repair procedure on the injured cartilage surface of the index knee
- Arthroplasty or open surgery of the index knee within 6 months of screening
- Intra-articular steroid injection in the index knee within 3 months of screening
- Intra-articular hyaluronic acid injection in the index knee within 6 months of
screening
- Other intra-articular therapy in the index knee within 6 months prior to screening
- Orally administered systemic steroid use within 2 weeks of screening
- Planned/anticipated surgery of the index knee during the study period
- Skin breakdown at the knee where the injection is planned to take place
- Pregnant or nursing mothers or women planning on getting pregnant during the time they
will be participating in the study
- Participated in any investigational drug or device trial within 30 days prior to
screening
- Participated in any investigational biologic trial within 60 days prior to screening
We found this trial at
27
sites
New Albany, Ohio 43054
Principal Investigator: Jason Hurst, MD
Phone: 614-221-6331
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Theodore Shybut, MD
Phone: 713-798-4516
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Kristofer Jones, MD
Phone: 310-794-2877
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Birmingham, Alabama 35294
Principal Investigator: Jasvinder Singh, MD
Phone: 205-934-1444
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: F. Winston Gwathmey, MD
Phone: 434-243-5653
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Cincinnati, Ohio 45267
Principal Investigator: Brian Grawe, MD
Phone: 513-584-3931
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281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Robert Magnussen, MD
Phone: 614-293-7952
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Thorsten Seyler, MD
Phone: 919-668-4373
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Elkhart, Indiana 46514
Principal Investigator: Jason Hix, MD
Phone: 574-264-0791
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Encinitas, California 92024
Principal Investigator: Christopher Hajnik, MD
Phone: 760-943-6700
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20 Patriot Place
Foxboro, Massachusetts 02035
Foxboro, Massachusetts 02035
Principal Investigator: Elizabeth Matzkin, MD
Phone: 617-525-8500
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1400 South Germantown Road
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Principal Investigator: Santos F. Martinez, M.D.
Phone: 901-759-5413
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865 Northern Boulevard
Great Neck, New York 11021
Great Neck, New York 11021
Principal Investigator: Nicholas Sgaglione, MD
Phone: 718-470-7320
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1020 Gulf Breeze Parkway
Gulf Breeze, Florida 32561
Gulf Breeze, Florida 32561
Principal Investigator: Brett Kindle, M.D.
Phone: 850-916-8590
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Guntersville, Alabama 35976
Principal Investigator: William A Nixon, MD
Phone: 256-763-0628
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Kansas City, Kansas 66160
Principal Investigator: Neil Segal, MD
Phone: 913-574-0961
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Orlando, Florida 32804
Principal Investigator: J. Dean Cole, MD
Phone: 407-303-1339
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Kentaro Onishi, D.O.
Phone: 412-692-2084
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Plano, Texas 75093
Principal Investigator: Roger Emerson, MD
Phone: 972-981-7114
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7858 Shrader Road
Richmond, Virginia 23294
Richmond, Virginia 23294
Principal Investigator: Kenneth R. Zaslav, MD
Phone: 804-270-1305
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San Francisco, California 94143
Principal Investigator: Brian Feeley, MD
Phone: 415-353-7987
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Tucson, Arizona 85713
Principal Investigator: Nebojsa Skrepnik, MD
Phone: 520-784-6481
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West Palm Beach, Florida 33409
Principal Investigator: Gary Ackerman, MD
Phone: 561-478-3177
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Winston-Salem, North Carolina 27157
Principal Investigator: Cristin Ferguson, MD
Phone: 336-716-5457
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