Clinical Trial Participation

Patients may be candidates for the PROGRESS IV clinical trial if they meet all of the following inclusion criteria:

  • Between 21 and 80 years old at 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 (defined as advanced stage osteoarthritis, including large osteophytes, chronic fractures or bone remodeling, severe deformity or bone attrition, and/or bone-on-bone contact indicative of severe osteoarthritis/full thickness cartilage loss), as confirmed by the central imaging laboratory
  • Body mass index ≤ 40 kg/m2
  • Has undergone at least one prior conservative osteoarthritis treatment (e.g. physical therapy, simple analgesics)

Patients are not candidates for the PROGRESS IV clinical trial if they meet any of the following 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
  • Clinically symptomatic patellofemoral chondromalacia (i.e. knee pain in the anterior knee only) or diagnosis of isolated patellofemoral OA
  • Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
  • Disease of spine, hip or other lower extremity joints judged by the investigator to be contributing to the pain in the index knee (i.e. sciatica, nerve pain, hip OA). Note: Patients with knee replacement at the contra-lateral knee or hip replacement in either hip may be enrolled provided there is sufficient pain relief after knee replacement or hip replacement that analgesics are not required.
  • Untreated symptomatic injury of the index knee (e.g., acute traumatic injury, anterior cruciate ligament injury, clinically symptomatic meniscus injury characterized by mechanical issue such as locking or catching)
  • Any condition other than OA of the index knee which, in the opinion of the investigator, affects the ability to ambulate to a sufficient degree to interfere with the assessment of the safety and treatment effects of the study injection
  • 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 (i.e., microfracture, Osteochondral Autograft Transfer System (OATS®) and autologous chondrocyte implantation (ACI)) of the index knee
  • Arthroscopy or open surgery of the index knee within 6 months prior to screening
  • Intra-articular steroid injection in the index knee within 3 months prior to screening
  • Intra-articular hyaluronic acid injection in the index knee within 6 months prior to screening
  • Other intra-articular therapy in the index knee within 6 months prior to screening
  • Orally administered systemic steroid use within 2 weeks prior to screening
  • Planned/anticipated surgery of the index knee during the study period
  • A history of local anesthetic allergy
  • Use of systemic immunosuppressants within 6 weeks prior to screening
  • Currently on anticoagulant therapy, such as Warfarin, vitamin K antagonists, direct thrombin inhibitors, or factor Xa inhibitors or on potent anti-platelet therapy, such as GPIIb-IIIa antagonists, Par-1 antagonists or dual anti-platelet therapy, i.e. an ADP receptor antagonist in combination with aspirin
  • Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection
  • 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
  • Known drug or alcohol dependence currently or within the last year
  • 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
Caution: Investigational device, limited by federal (or United States) law to investigational use.
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