Clinical Trial Design

The PROGRESS IV clinical trial will randomly assign patients to receive either a single injection of autologous protein solution OR saline. To participate in the trial, patients must have early to moderate symptomatic OA in one knee and have failed at least one prior conservative OA therapy.

Participation will require at least six doctor’s office visits over a maximum period of 16 months. The schedule of visits is as follows:

  • Screening visit (includes an X-Ray and MRI)
  • Injection visit (within 28 days of screening)
  • Follow-up visit one month after injection
  • Follow-up visit three months after injection 
  • Follow-up visit six months after injection 
  • Follow-up visit 12 months after injection (includes an X-Ray and MRI to assess anatomical changes)

After the 12 month visit, patients may choose to receive an injection of APS. If you do choose to receive another injection, you will have two additional visits:

  • Second injection visit
  • Second injection follow-up visit one month after second injection

Patients should not enroll in the trial unless they are willing and able to honor the time commitment outlined above.

Clinical Trial Risks

Potential risks involved with participating in the PROGRESS IV clinical trial may include side effects such as bruising, local pain or swelling associated with the blood draw, joint fluid aspiration or knee injection. Other possible risks include infection at the injection site, fainting, scar tissue formation or nerve/nervous system damage. There are risks associated with MRI and X-Ray procedures, such as exposure to radiation and anxiety. Your osteoarthritis may not improve or may get worse. Your doctor will discuss all the possible risks with you before you choose to participate in the trial.

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