Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Os… (NCT06329492) | Clinical Trial Compass
CompletedPhase 1/2
Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis
United States20 participantsStarted 2024-01-09
Plain-language summary
The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Painful knee OA in one or more knee compartments grade 2-3 radiologic severity based upon the Kellgren-Lawrence grading scale, without evidence of advanced (bone on bone, as determined by study investigators) OA in the patellofemoral compartment or on Posterior Anterior (PA) flexion views
✓. Cognitive ability to give informed consent
✓. Speak fluent English
✓. Worst knee pain greater than 4 on a 0-10 pain scale (0 = no pain, 10 = worst pain imaginable)
✓. Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications/acetaminophen or injection therapy (e.g., cortisone)
✓. Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including blood draw, laboratory tests, diagnostic imaging, and follow-up visits and assessments
Exclusion criteria
✕. Pregnant or nursing, or planning on becoming pregnant during the study period
✕. Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results
. Significant valgus or varus malalignment as determined by investigator
✕. Injections of any kind into the target knee:
✕. History of intra-articular infection in the target knee
✕. History of superficial infection in the target knee within 6 months of study enrollment, or evidence of current superficial infection affecting the target knee
✕. Body mass index (BMI) \< 35 kg/m2
✕. Inability to stop non-steroidal anti-inflammatory medications for 1 week before through 2 weeks after the procedure date