Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02905240
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zimmer Biomet
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Frederick M Azar, M.D.
Principal Investigator Affiliation	Campbell Clinic Orthopaedics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama

Birmingham, Alabama, 35294

Site Contact

Stephanie Biggers, RN

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