Clinical Trial Purpose
The PROGRESS IV clinical trial will compare the efficacy of autologous protein solution (APS), prepared using the investigational nSTRIDE APS Kit, and saline in patients with early to moderate symptomatic knee osteoarthritis (OA) in one knee, who have failed at least one prior conservative OA therapy (e.g. physiotherapy, simple analgesics).
Clinical Trial Design
The PROGRESS IV clinical trial is a double-blind, multicenter, randomized, controlled trial (RCT) with patients receiving either a single injection of APS or saline. During the injection visit, all patients will have a blood draw, from which the APS will be prepared for injection and for laboratory characterization. After all available joint fluid is aspirated, and appropriate to randomization group, approximately 2.5 mL of APS or saline will be injected into the joint. A blinding sleeve covering the contents of the syringe will be utilized to mask the group assignment from the patient and the injecting physician, and needle placement will be verified using ultrasound. Any adverse events associated with the blood draw and/or injection procedure will be recorded. All subjects should be instructed not to exceed the pre-injection level of activity for 14 days.
Efficacy and safety will be assessed at 1, 3, 6, and 12 months post-injection. An X-Ray and MRI will be obtained at baseline and at 12 months to assess anatomical changes. Upon completion of all 12 month follow-up evaluations, group allocation will be unblinded, and patients from both groups will be permitted to enter a one month open-label repeat injection phase if they had no major safety concerns due to the first injection.
Potential risks for patients 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. The patient’s osteoarthritis may not improve or may get worse.