Clinical Trial Participation

If you meet all of the following inclusion criteria, you may be a candidate for the PROGRESS IV clinical trial:

• Between 21 and 80 years old
• Willing and able to comply with the trial procedures and visit schedules
• Symptomatic osteoarthritis in only one knee
• Body mass index ≤ 40 kg/m²
• At least one prior conservative osteoarthritis treatment without satisfactory pain relief

If you meet any of the following exclusion criteria, you may not enroll in the PROGRESS IV clinical trial:

• Presence of symptomatic osteoarthritis in the non-study knee
• Diagnosed with: 
  • Rheumatoid arthritis, psoriatic arthritis, gout or ankylosing spondylitis
  • Conditions affecting the joints, such as Reiter’s syndrome and arthritis resulting from other medical conditions
  • HIV or viral hepatitis
• Pain or osteoarthritis isolated at the front of the knee
• Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
• Untreated symptomatic injury of the study knee (e.g. injury to ACL or meniscus)
• Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the study knee
• Previous cartilage repair procedure on the injured cartilage of the study knee
• Arthroscopy or open surgery of the study knee within 6 months prior to screening
• Steroid injection of the study knee joint within 3 months prior to screening
• Hyaluronic acid injection of the study knee joint within 6 months prior to screening
• Other joint injections in the study knee within 6 months prior to screening
• Orally administered systemic steroid use within 2 weeks prior to screening
• Planned/anticipated surgery of the study 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, potent anti-platelet therapy or dual anti-platelet therapy
• Pregnant or nursing mothers or women planning on getting pregnant during the time they will be participating in the study
• Drug or alcohol dependence currently or within the last year
• Participation in any investigational drug or device trial within 30 days prior to screening
• Participation in any investigational biologic trial within 60 days prior to screening

For more information, please contact your doctor.

Caution: Investigational device, limited by federal (or United States) law to investigational use.

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